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 2017-04-20 for INDY OTW VASCULAR RETRIEVER N/A INDY-8.0-35-100-40 manufactured by Cook Inc.
[73330761]
(b)(4). Pma/510(k) # k160593. The device has been requested and not yet received. The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[73330762]
It was reported that during an inferior vena cava (ivc) retrieval procedure using an indy otw vascular retriever, the entire tip of the indy otw vascular retriever broke off and ventured into the ventricle. With the use of another manufacturer's device, the physician was able to retrieve all pieces of the indy otw vascular retriever. It was reported that the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-00686 |
| MDR Report Key | 6508191 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-20 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-10-06 |
| Device Manufacturer Date | 2016-07-26 |
| Date Added to Maude | 2017-04-20 |
| 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 | 8123392235 |
| 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 | 2017-04-20 |
| Model Number | N/A |
| Catalog Number | INDY-8.0-35-100-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-04-20 |