MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-04-14 for KOLENDA SALIVARY ACCESS INTRODUCER SET SDAS N/A UNKNOWN manufactured by Cook Inc.
[72837571]
Unknown date and month. Year of the event: 2015. Patient code: no known impact or consequence to patient reported. (b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[72837572]
It was reported that the physician was performing a submandibular gland duct sialoendoscopy procedure on a male patient by using a kolenda salivary access introducer set. The physician used the device for three times, however it caused perforation of the salivary duct for two times. The physician further stated that this was all of the information they were able to recall about the event. No unintended section of the device remained inside the patients? Body. The patient did not require an additional procedure due to this occurrence. According to the initial reporter, the patient did not experienced any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[74719646]
Investigation - evaluation: a review of the complaint history, documentation, instructions for use (ifu), specifications and quality control of the returned device was conducted during the investigation. The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: the product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of salivary access should be employed. When inserting, manipulating or withdrawing a device through an introducer, always maintain introducer position. Do not attempt in the presence or suspected presence of unfavorable patient anatomy. If resistance is encountered, do not force; damage to the sheath and/or duct may occur. ? The physician stated it was "one of the first" he had done "with the introducer. " there is no information regarding the circumstances that occurred during the procedure that could have contributed to the perforation of the salivary duct. There is no information regarding any of the patient's anatomical characteristics such as the perforation from an existing salivary stone. The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. Review of device history record shows no nonconforming events which could contribute to this failure mode. It should be noted there were no other reported complaints for this lot number. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2017-00672 |
| MDR Report Key | 6493763 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-14 |
| Date of Report | 2017-05-08 |
| Date Mfgr Received | 2017-05-03 |
| Date Added to Maude | 2017-04-14 |
| 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 |
| Reporter Occupation | OTHER CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOLENDA SALIVARY ACCESS INTRODUCER SET SDAS |
| Product Code | OAJ |
| Date Received | 2017-04-14 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-14 |