MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-07 for CLOVERSNARE? 4-LOOP VASCULAR RETRIEVER N/A VRS-6.0-90 manufactured by Cook Inc.
[85597566]
(b)(4). A review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation. Only the outer sheath of the device was returned. A non-cook stopcock was also returned attached to the outer sheath proximal fitting. The sheath was noted to be kinked 9. 5cm from proximal hub. The device was tested for leaks with the non-cook stopcock attached. There was a dripping leak at the proximal end of the sheath fitting. The syringe was then connected directly to the sheath proximal fitting and the leak was still present. No cracks were noted. There appeared to be inadequate seating. The fitting of the outer sheath was examined and appeared to be damaged at the threads. The proximal fitting was pulled and was secure. Leak test found leakage at the threading of the proximal fitting of the outer sheath. There is no evidence to suggest the finished product was not made to specifications. Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode. There were no other reported complaints for this lot number. Measures have been conducted to address this failure mode. Monitoring will continue to be performed for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[85597567]
An international customer reported that when the final venography was performed during an inferior vena cava filter removal, the luer lock of the cloversnare 4-loop vascular retriever outer sheath was leaking. A section of the device did not remain inside the patient and no additional procedures were required due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-02831 |
| MDR Report Key | 6849429 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-07 |
| Date of Report | 2017-09-07 |
| Date of Event | 2016-12-06 |
| Date Mfgr Received | 2017-08-28 |
| Device Manufacturer Date | 2016-06-02 |
| Date Added to Maude | 2017-09-07 |
| 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 | CLOVERSNARE? 4-LOOP VASCULAR RETRIEVER |
| Generic Name | MMX DEVICE, PERCUTANEOUS RETRIEVAL |
| Product Code | MMX |
| Date Received | 2017-09-07 |
| Model Number | N/A |
| Catalog Number | VRS-6.0-90 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-09-07 |