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 2019-04-25 for CLOVERSNARE? 4-LOOP VASCULAR RETRIEVER VRS-6.0-90 manufactured by Cook Inc.
[144152467]
Lot number = unknown. Retrieval of filter leg captured under report reference number 3002808486-2019-00119. This report includes information known at this time. A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[144152468]
As reported, during retrieval of a cook celect filter, a cloversnare 4-loop vascular retriever malfunctioned. The snare reportedly connected? Nicely? To the hook of the filter, but was not able to be retracted. During attempted removal with the complaint device, a leg of the filter fractured (reported under reference number 3002808486-2019-00119). The filter and fractured leg were retrieved with a second snare. When the cook celect filter was returned to the corresponding manufacturer, the complaint device was received with it. Upon receipt of the complaint device, separation was observed near the distal end, as well as accordion damage near the proximal end. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence. 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
| Report Number | 1820334-2019-00880 |
| MDR Report Key | 8552109 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-25 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-04-29 |
| Date Added to Maude | 2019-04-25 |
| 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 |
| 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 | CLOVERSNARE? 4-LOOP VASCULAR RETRIEVER |
| Generic Name | MMX DEVICE, PERCUTANEOUS RETRIEVAL |
| Product Code | MMX |
| Date Received | 2019-04-25 |
| Returned To Mfg | 2019-04-16 |
| Catalog Number | VRS-6.0-90 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-04-25 |