MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-04-22 for INDY OTW VASCULAR RETRIEVER INDY-8.0-35-100-40 manufactured by Cook, Inc..
[16609305]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[16633708]
An evar with a iliac branch device implantation was being performed on a (b)(6) male patient. The doctor caught the wire in the snare and pulled with some force. The indy snare snapped and was left floating within the aorta. A clover snare was then used to retrieve the part of the indy. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[60014256]
The complaint device was returned and imaged upon receipt. A review of the manufacturing record does not indicate any instances of rework or non-conformance all (b)(4) units of the lot passed quality control and were released. The device ifu states under precautions, "this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. " visual inspection of the returned complaint device confirms that the indy snare broke. The separation occurred at the distal catheter within the area wrapped by the nylon string just proximal to where the braided wires of the snare emerge. The force exerted by the physician operating the complaint device was significant such that the proximal cannula was slightly bent and the catheter distal to the snare loops was also bent and stretched. It is possible that the operator exerted excessive force upon the snare causing the catheter to break. We will continue our monitoring of similar complaints and have notified the appropriate internal personnel of this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2015-00215 |
| MDR Report Key | 4730748 |
| Report Source | 01,08 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-03-26 |
| Date of Event | 2015-03-26 |
| Date Facility Aware | 2015-03-26 |
| Report Date | 2015-03-26 |
| Date Mfgr Received | 2015-03-30 |
| Device Manufacturer Date | 2015-02-20 |
| Date Added to Maude | 2015-04-28 |
| 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 | LARRY POOL,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 | 2015-04-22 |
| Returned To Mfg | 2015-04-21 |
| Model Number | NA |
| Catalog Number | INDY-8.0-35-100-40 |
| Lot Number | 5667083 |
| ID Number | NA |
| Device Expiration Date | 2018-02-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2015-04-22 |