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 2017-08-09 for CLOVERSNARE? 4-LOOP VASCULAR RETRIEVER N/A VRS-6.0-90 manufactured by Cook Inc.
[82124832]
(b)(4). The reported device is not available for evaluation. The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[82124833]
A cloversnare? 4-loop vascular retriever was used for a filter retrieval procedure. It was reported that the sheath did not allow the tuoy to have a secure fit. It was leaking. The end user tried different tuoys which did not resolve the problem. There was no section of the device that remained in the patient's body , the patient did not require any additional procedures due to this occurrence and there were no adverse effects to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-02314 |
| MDR Report Key | 6776501 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-09 |
| Date of Report | 2017-11-02 |
| Date Mfgr Received | 2017-10-13 |
| Date Added to Maude | 2017-08-09 |
| 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 HEALTH CARE PROFESSIONAL |
| 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 | CLOVERSNARE? 4-LOOP VASCULAR RETRIEVER |
| Generic Name | MMX DEVICE, PERCUTANEOUS RETRIEVAL |
| Product Code | MMX |
| Date Received | 2017-08-09 |
| Model Number | N/A |
| Catalog Number | VRS-6.0-90 |
| 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 | 2017-08-09 |