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 2019-05-21 for WITTICH NITINOL STONE BASKET N/A WNSB-12-24 manufactured by Cook Inc.
[145650647]
Concomitant medical products: terumo wire guide. 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
[145650648]
It was reported a wittichi nitinol stone basket was used for biliary stone removal. As reported, the basket sheath and sheath hub were separated. The device was removed without any problems and another product of the same type was used. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00990 |
| MDR Report Key | 8627905 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-21 |
| Date of Report | 2019-09-03 |
| Date of Event | 2019-05-13 |
| Date Mfgr Received | 2019-08-27 |
| Date Added to Maude | 2019-05-21 |
| 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 | WITTICH NITINOL STONE BASKET |
| Generic Name | LQR DISLODGER, STONE BILIARY |
| Product Code | LQR |
| Date Received | 2019-05-21 |
| Returned To Mfg | 2019-05-23 |
| Model Number | N/A |
| Catalog Number | WNSB-12-24 |
| 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 | 2019-05-21 |