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 2017-09-07 for CLOVERSNARE? 4-LOOP VASCULAR RETRIEVER N/A VRS-6.0-90 manufactured by Cook Inc.
[85339284]
Blank fields on this form indicate the information is unknown or unavailable. (b)(4). A review of the complaint history, drawings, trends, quality control, and visual inspection / functional testing of the returned device was conducted during the investigation. The customer returned one introducer sheath assembly. A luer lock syringe filled with water was attached to the hub of the outer sheath. Then the sheath was flushed and clamped. Leakage at the joint between the syringe and outer sheath hub was confirmed when fluid was injected. When attempting to further tighten the syringe onto the hub, the threads slipped and the syringe continued to rotate. There did not appear to be any physical damage to the outer sheath hub. Upon repeating the failure analysis, the proximal fitting was pulled and was secure but leakage was noticed at the threads of the outer sheath. The root cause was determined to be design-related. 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
[85339285]
It was reported that during a filter retrieval procedure, after the physician removed the filter he attached a flow switch to the outer sheath of the cloversnare 4-loop vascular retriever. At that point, the outer sheath was leaking at the flow switch. A final cavagram was not able to be performed without exchanging the sheath. 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 | 1820334-2017-02124 |
| MDR Report Key | 6848495 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-07 |
| Date of Report | 2017-09-07 |
| Date of Event | 2016-01-14 |
| Date Mfgr Received | 2017-08-28 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| 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 |