MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-02 for CLOVERSNARE? 4-LOOP VASCULAR RETRIEVER VRS-6.0-90 manufactured by Cook Inc.
[107503609]
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[107503610]
It was reported that after snaring the filter, while putting tension on the proximal clover snare catheter, the catheter fractured and came apart. A separation occurred below the hub. The filter was successfully retrieved without harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01369 |
| MDR Report Key | 7480623 |
| Date Received | 2018-05-02 |
| Date of Report | 2018-05-02 |
| Date of Event | 2016-09-08 |
| Date Mfgr Received | 2018-05-02 |
| Device Manufacturer Date | 2016-04-08 |
| Date Added to Maude | 2018-05-02 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLOVERSNARE? 4-LOOP VASCULAR RETRIEVER |
| Generic Name | MMX DEVICE, PERCUTANEOUS RETRIEVAL |
| Product Code | MMX |
| Date Received | 2018-05-02 |
| Catalog Number | VRS-6.0-90 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-05-02 |