MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2011-06-06 for INDY OTW VASCULAR RETRIEVER INDY-8.0-35-44-40 manufactured by Cook, Inc..
[2055845]
The physician was performing a percutaneous transhepatic cholangiography with removal of an endoscopic drain on a (b)(6) male patient. During the use of the indy retriever to retrieve the biliary stent, the retrieval snare snapped at the shaft during attempted removal of the biliary stent, resulting in half of the retrieval device being left in the patient with a prolapsed biliary stent folded over on itself and obstructing the common bile duct. Subsequently, a bcl catheter was able to be placed for maintaining biliary access, but there was profuse bleeding from the liver. A rendezvous procedure was completed to remove the separated device. The patient experienced repeat biliary cholangiogram, endoscopy and ct scan.
Patient Sequence No: 1, Text Type: D, B5
[9015208]
Expiration - unknown as lot is unknown. (b)(4). No product was returned to assist in this investigation. However, a photo of the complaint device was provided to assist in this investigation. Quality control performs a 100% inspection to verify surface of entire device is free of excessive dents, bumps, scratches, cracks and foreign matter prior to further processing. Without an examination of the complaint device, we can only speculate on possible causes. The accompanying photograph and event description confirms that the break occurred at the catheter shaft. (b)(4). The device in the provided photo image does not appear to have undergone any sizeable extension, therefore, it is feasible to propose that the device catheter suffered some type of damage that resulted in a loss of integrity and reduction in its tensile strength. This complaint is more likely the result of user technique or handling prior to use. We will continue to monitor for similar complaints. No action is necessary at this time as there is insufficient risk per quality engineering risk assessment (qera).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2011-00292 |
| MDR Report Key | 2127059 |
| Report Source | 01,08 |
| Date Received | 2011-06-06 |
| Date of Report | 2011-05-17 |
| Date of Event | 2011-05-17 |
| Date Facility Aware | 2011-05-17 |
| Report Date | 2011-05-17 |
| Date Mfgr Received | 2011-05-18 |
| Date Added to Maude | 2011-06-17 |
| 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 Contact | RITA HARDEN, MANAGER |
| 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 | INDY OTW VASCULAR RETRIEVER |
| Generic Name | GAE SNARE, SURGICAL |
| Product Code | GAE |
| Date Received | 2011-06-06 |
| Model Number | NA |
| Catalog Number | INDY-8.0-35-44-40 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-06-06 |