MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-14 for INDY OTW VASCULAR RETRIEVER G51835 INDY-8.0-35-55-40 manufactured by Cook Inc.
[111136356]
(b)(4). Pma/510(k): k160593. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[111136357]
It was reported the doctor was using an indy otw vascular retriever with exceptional force and it eventually broke. As reported, the doctor was attempting to retrieve a covered balloon expandable stent that had come off its balloon. The physician was not doing this over a wire. At the time, the doctor was advised this was off label use of the device. It was obvious that the stent the doctor was attempting to retrieve was jammed/stuck in the patient somehow. He was applying significant force and began to pull the inner segment of the snare out through the outer sheath. The doctor was advised that the snare and sheath are supposed to be removed together and with less force applied. Upon removal of the snare it was found that the wire loops of the snare were still inside the patient. The wires loops were later retrieved with alligator forceps. There was no unintended section of the device remaining inside the patient? S body. The patient did not require any additional procedures and did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01864 |
| MDR Report Key | 7603359 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-14 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2018-06-14 |
| 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 |
| 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 | 8128294891 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDY OTW VASCULAR RETRIEVER |
| Generic Name | MMX DEVICE, PERCUTANEOUS RETRIEVAL |
| Product Code | MMX |
| Date Received | 2018-06-14 |
| Model Number | G51835 |
| Catalog Number | INDY-8.0-35-55-40 |
| Lot Number | 8552387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2018-06-14 |