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 2018-07-16 for CLOVERSNARE? 4-LOOP VASCULAR RETRIEVER VRS-6.0-90 manufactured by Cook Inc.
[114154636]
Per the initial reporter, the device will not be returned. (b)(4). 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
[114154637]
It was reported, during another manufacturer's inferior vena cava (ivc) filter removal, it was discovered the inner lumen of the outer 10 french (fr) cloversnare? 4-loop vascular retriever sheath was frayed. After retrieval of the ivc filter, blue plastic material was noted when the sheath was flushed outside of the patient's vasculature. The filter is intact. The sheath was damaged by the legs of the ivc filter. During follow up of the event, it was reported the access site was the right internal jugular vein. No vessel scarring, calcification, or tortuosity was noted; however, there was tissue indwell growth at the feet of existing ivc filter. 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 | 1820334-2018-02079 |
| MDR Report Key | 7690967 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-16 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-07-02 |
| Date Mfgr Received | 2018-10-05 |
| Device Manufacturer Date | 2018-03-21 |
| Date Added to Maude | 2018-07-16 |
| 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 |
| 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 | 2018-07-16 |
| Catalog Number | VRS-6.0-90 |
| Lot Number | 8684118 |
| 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 | 2018-07-16 |