MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for DOPPLER PROBE 240 HOUR DP240 9070-7006 manufactured by Deltex Medical Ltd.
[122802881]
Notification and subsequent events: on the (b)(6), (senior medical device specialist, (b)(6)) was contacted and notified of the incident and that we would be filing an initial report in the next few days once a copy of the surgeon and anesthetist incident report is received. To assist deltex medical with its investigation, the (b)(6) was requested if it would be possible to supply information concerning incidents of ng tube where they were involved in the perforation of the pharynx. (b)(6) stated that he would discuss the matter with one of his colleagues who dealt with this specific area. On the 30th of october, deltex medical received the original report submitted to the hospital's mta department. The mta is responsible for testing the safety of all equipment used with patients and for testing after malfunctions. In an email of the same date, dr (b)(6) stated that he had spoken to the person in charge and it transpired that the mta department was not proceeding to file a report with their competent authority. The reason for this was that neither dr (b)(6) nor the surgeon suspected any malfunction of the equipment during the procedure. He also confirmed that the patient continues to recover well, was eating normally and was expected to be discharged this week. On the (b)(6), dr (b)(6) confirmed by email that the patient had made a full recovery and had been discharged. The patient began eating before she left the hospital, having previously been fed by way of a gastronomy. The change to solid food went satisfactorily. Summary: dr (b)(6) reports that he suggests the most likely cause of the perforation is the combination of probe + ng tube + manipulation of the esophagus whose anatomy was not quite normal. The result was that the tip of the esophageal doppler probe was oppressed through the wall causing the perforation. He states that he thinks it is significant that the probe appeared to be correctly placed initially as the surgeon thought he could feel something in the esophagus at the start (leading him to ask whether it was an ng tube). Dr (b)(6) has confirmed that in his opinion the dp240 was associated with the events as described but could not be conclusively found to be the cause of the perforation. Deltex medical does not accept causality for this near incident.
Patient Sequence No: 1, Text Type: N, H10
[122802882]
Date of incident: (b)(6) 2006. Reported complaint: on the (b)(6), our international sales manager ((b)(4)) received an email from dr (b)(6) at (b)(6). The report related to the perforation of the esophagus of a (b)(6) year-old woman during hiatus hernia repair on the (b)(6). Dr (b)(6) reported that a dp240 esophageal doppler probe manufactured by deltex medical ltd. Had been in use during the operation and may have been associated with the perforation of the esophagus. Dr (b)(6) is an ex-patriot living and working in (b)(6). He is an experienced user of the cardioq esophageal doppler monitor and the dp240 probe. He has previously attended training in the technology at the (b)(6) hospital on a 2-day course run by dr (b)(6). Dr (b)(6) and his colleagues are sufficiently experienced to have recently set up sos as a regional training centre for esophageal doppler monitoring during surgery. Hiatus hernia and probe location: normally, the stomach is completely below the diaphragm. The weakest part of the diaphragm is around the hole through which the esophagus passes. A hiatus hernia forms when part of the stomach slides through this hole (hiatus) into the chest cavity. Repair of a hiatus hernia involves penetration of both the abdomen and the thorax (by way of the abdomen through the herniated diaphragm). The dp240 esophageal doppler probe is placed in the esophagus to monitor blood flow in the descending aorta by way of ultrasound measurement of the doppler shift resulting from blood flow. Typically, the probe is in focus when facing the aorta at about the t5 - t6 level. This would mean that the tip of the probe would be 6 to 7 cm above the junction of the stomach and esophagus. Circumstances of the incident: the patient was reported to be overweight, with high blood pressure and was also dehydrated as the symptoms related to the hiatus hernia made it difficult for her to eat or drink normally and the operation was planned semi acutely. The patient was anaesthetized and intubated. As usual, the esophageal doppler probe was inserted and a good cardiac output signal obtained within 90 seconds and the anesthetist noted that the patient was hypovolemic (the blood pressure had also fallen on induction). Dr (b)(6) reports that "everything was going well" and he noted that it was easy to insert the probe via a guedel airway as is his normal practice. After about 30 minutes, the surgeon felt the probe whilst manipulating the esophagus and asked if the probe was a naso-gastric tube (ng tube). Dr (b)(6) advised that it was an esophageal doppler probe. The surgeon requested an ng tube be inserted into the patient's stomach. A 14 or 16 french pvc ng tube (exact size unknown) was introduced via the patient's nose. The surgeon confirmed he could feel the ng tube entering the stomach. The ng tube was placed to empty the stomach and for use in the post-operative period to drain the stomach and help in the prevention of nausea and vomiting. After approximately 30 minutes, the surgeon said he could feel the esophageal doppler probe tip and that he thought it was outside the esophagus - that it had perforated the esophageal wall. The operation was stopped and the dp240 probe and ng tube were withdrawn and endoscopy was conducted, which confirmed that there was a perforation in the posterior wall of the esophagus. The perforation was found to be 7cm above the oesophagogastric junction. This was subsequently repaired with clips endoscopically and then the hiatus hernia repair operation was completed. Patient condition postoperatively: dr (b)(6) has reported that the patient woke up fine and was feeling well postoperatively. On the (b)(6), the patient underwent a barium swallow procedure and this confirmed there were no leaks from the perforation. Dr (b)(6) reported in a telephone discussion that the perforation could have been life threatening if not detected and the anesthetist and surgeon had reported the event internally to the hospital mta department. The patient was also notified of the event and has been advised of her rights to claim on hospital insurance if necessary. Anesthetist comments: dr (b)(6) reports that he is uncertain as to precisely when and how the incident happened. He believes that it is unlikely that the perforation occurred when he put the probe down initially. Firstly, as it was so easy to insert. Secondly, as the surgeon had felt it inside the esophagus 30 minutes into the procedure and it was not reported to be protruding at that time. Thirdly, it is unlikely dr (b)(6) would have obtained a signal from the descending aorta if the probe was protruding from the esophagus. The latter would be for two reasons: a protruding probe would not achieve the precise angle necessary for signal acquisition, and secondly, once the abdomen and thorax (via the abdominal hernia region) were opened surgically, air around the probe would have been a barrier to ultrasound measurements. Dr (b)(6) has considered whether perforation could have been as a result of pushing the ng tube past the esophageal doppler probe, but he cannot be certain. A second possibility is that the patient's hernia resulted in stricture of the esophagus or thirdly, that manipulation of the surgical site during the surgery may have resulted in perforation with the probe and ng tube in place. Whilst the dp240 probe was not retained post operatively, it was inspected by both dr (b)(6) (anesthetist) and dr (b)(6) (surgeon) and no unusual observations were made. The probe tip was intact and of normal appearance.
Patient Sequence No: 1, Text Type: D, B5
[123073648]
Label copy review: deltex medical, although not accepting causality for the incident, has proactively conducted a label copy review to identify if any improvements could be made. The review included the operating handbook for the cardioq esophageal doppler monitor, on-screen and hard copy instructions for use (ifu) and indications provided on pouch and flag labelling across the complete deltex medical device range. The review concluded that the cardioq operating handbook provides adequate warning in that 'the probes should not be used in patients with conditions which carry the risk of causing injury or perforations, with carcinoma of the pharynx, larynx or esophagus, with aneurisms of the thoracic aorta, with proximal coarctation of the aorta, or with tissue necrosis'. The contraindications also include 'known pharyngo-esophago- gastric pathology and/or severe bleeding diatheses'. However, there was no specific mention of contraindications specifically related to hiatus hernia or positioning in relation to naso-gastric tubes. Furthermore, the operating handbook states 'no major esophageal complications have been reported with probe use. As with any naso-gastric or naso-esophageal tube/probe, some local inflammation can be seen on endoscopy after a number of days, though this has not caused any problem to date. No special precautions need to be taken apart from not being overly vigorous on probe insertion'. Review of the hard copy ifu, which includes the dp240 esophageal doppler probe that is placed in the probe shelf box did not contraindicate 'known pharyngo-esophago-gastric pathology and/or severe bleeding diatheses'. Review of the cardioq monitor on-screen ifu found that it did not contraindicate 'pharyngo-esophago-gastric pathology and/or severe bleeding diatheses' however a warning - 'do not place probes in patients with conditions which carry the risk of causing injury; with carcinoma of the pharynx or esophagus; or with severe coarctation of the aorta' was made. After completion of the label copy review, we are adding to ifu's of all probe variants the additional caution 'not for use in patients with pharyngo-esophago-gastric pathology and/or severe bleeding diatheses'. Conclusion: deltex medical has reviewed and improved the instructions for use for all doppler probes. Signed on behalf of deltex medical ltd. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123073709]
Near incident final report: this report concludes the initial report mdr 003 sent to the mdr reporting, center for devices and radiological health on the 16th november 2006 and details events subsequent to this report with actions taken by deltex medical to further understand the incident and improve product safety. Hospital visit: on (b)(6) (b)(4) visited (b)(6) and met with dr (b)(6) to discuss the incident. No further info could be gained to identify the root cause of the incident although dr (b)(6) concluded that manipulation of the esophagus with naso-gastric tube (ng tube) and esophageal doppler probe in situ was probably not best practice. Dr (b)(6) has advised us that the hospital has reviewed practices in upper gi surgery and consider the matter closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680933-2006-00003 |
| MDR Report Key | 7925527 |
| Date Received | 2018-10-01 |
| Date of Event | 2006-10-19 |
| Date Facility Aware | 2006-10-19 |
| Report Date | 2006-11-16 |
| Date Reported to FDA | 2006-11-16 |
| Date Mfgr Received | 2006-10-20 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2018-10-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | TERMINAS ROAD |
| Manufacturer City | CHICHESTER, WEST SUSSEX PO 198TX |
| Manufacturer Country | UK |
| Manufacturer Postal | PO 19 8TX |
| Manufacturer Phone | 1243774 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DOPPLER PROBE 240 HOUR |
| Generic Name | DP240 |
| Product Code | DPT |
| Date Received | 2018-10-01 |
| Model Number | DP240 |
| Catalog Number | 9070-7006 |
| Lot Number | 5574U |
| Device Expiration Date | 2009-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 37 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DELTEX MEDICAL LTD |
| Manufacturer Address | TERMINUS RD. CHICHESTER, WEST SUSSEX PO198TX UK PO19 8TX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-01 |