MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2014-11-21 for PROTOCO2L VC ADMINISTRATION SET FOLEY TIP 6470 manufactured by Ezem.
[5058153]
On (b)(6) 2013 (b)(4), a bracco distributor in (b)(6) received info which was forwarded to bracco on (b)(6) 2014. A staff member of a hosp user facility reported; a malfunction with the protoco2l administration set for colon insufflation occurred. On (b)(6) 2014, a female patient (in her 80s) underwent a colonoscopy at a hosp, but the colonoscopy was discontinued due to difficulty inserting the colonoscope. The patient subsequently complained of abdominal pain and was hospitalized for f/u examinations. The next day, on (b)(6) 2014, a ct colonography was performed at another hospital. Pre-treatment for the ct colonography was unk because it was conducted at a different hosp. The reporter stated that it was likely that the pre-treatment was similar to that for a colonoscopy. A protoco21 administration set for colon insufflation (list number 6470 lot number 50684022 (b)(6) 2014 single use device) was used for the procedure. The administration set rectal catheter balloon cuff volume was initially inflated with 25cc. Approx five minutes after the examination started (co2 insufflation), it was found that the patient had anal sphincter laxity compared with other patients. It was also confirmed that gas escaped through the anus. To continue the examination, the balloon volume was increased from 25cc to 35cc by inflating it with an additional 10cc. When the catheter was slightly pulled back to fix the balloon in the anus, it extruded from the anus. As a result the balloon ruptured. The reporter stated that the balloon did not explode, and the patient didn't recognize the rupture. The administration set (catheter) was then exchanged for a new one to complete the ct colonography. The patient returned home. There were no problems with the patient's condition at the time when the problem occurred. A concomitant device, the protoco2l insufflation system, bracco catalogue number 6400 serial number (b)(4), was used in conjunction with protoco21 administration set for colon insufflation for the ct colonoscopy procedure. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12505399]
Company comments: manufacturing narrative-bracco markets 2 device products used together to perform ct colonography. One is the protoco2l colon insufflator system which administers carbon dioxide during ct colonography for colon insufflation. The protoco2l is a concomitant device and no malfunction or problem was reported with its use. The reporter said the volume of co2 administered was between 1. 5 to 2. 0 liters and the pressure was 19 mmhg. The suspect device in this report is for the single use administration set used with the protoc2l insufflator. The set has a connector at one end which is inserted into the gas output of the protoco21 colon insufflator system. The other end of the administration set has a silicone rectal catheter with a balloon cuff for insertion into the patient's rectum. Co2 gas is delivered from the protoco2l insufflation system through the administration set to the patient's colon. The administration set also includes a syringe for inflating the balloon cuff. The package insert labeling includes an instruction to lubricate the catheter and retention cuff prior to insertion into the rectum and to inflate the balloon to 30cc using the provided syringe. For this procedure, the catheter cuff was inflated to 35cc. The balloon cuff ruptured during the procedure; however, there was no harm to the patient. A quality investigation is ongoing to determine the cause for this device failure. Company comment: the reported event describes a failure of the device during patient use. There was no adverse event of harm to this patient resulting from this failure. Additionally the labeling for the retention cuff states in capital lettering do not inflate the cuff with more than 30cc of air. Based on the above, even though the event did not cause patient harm and the cuff was over inflated according to instructions, we decided to take a conservative approach and to report this case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411512-2014-00012 |
| MDR Report Key | 4305710 |
| Report Source | 01,05,06,08 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-10-21 |
| Date of Event | 2014-10-22 |
| Date Mfgr Received | 2014-10-21 |
| Date Added to Maude | 2014-12-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 259 PROSPECT PLAINS RD, BLD. H. |
| Manufacturer City | MONROE TWP. NJ 08831 |
| Manufacturer Country | US |
| Manufacturer Postal | 08831 |
| Manufacturer Phone | 8002575181 |
| Manufacturer G1 | EZEM |
| Manufacturer Street | 532 BROADHOLLOW RD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTOCO2L VC ADMINISTRATION SET FOLEY TIP |
| Generic Name | PROTOCO2L VC ADMINISTRATION SET FOLEY TIP |
| Product Code | FCX |
| Date Received | 2014-11-21 |
| Model Number | NI |
| Catalog Number | 6470 |
| Lot Number | 50684022 |
| ID Number | NA |
| Device Expiration Date | 2015-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EZEM |
| Manufacturer Address | 532 BROADHOLLOW RD, STE 126 MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-21 |