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 2019-05-29 for WITTICH NITINOL STONE BASKET N/A WNSB-12-24 manufactured by Cook Inc.
[146649352]
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
[146649353]
It was reported a wittich nitinol stone basket was used in an unknown patient for a biliary stone removal procedure. As reported the "basket sheath and hub separated too easy (sic)". The user attempted to use another device from the same lot but experienced the same failure. No portion of the devices were left inside the patient. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence. Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01343 |
| MDR Report Key | 8651168 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-29 |
| Date of Report | 2019-07-13 |
| Date of Event | 2019-05-27 |
| Date Mfgr Received | 2019-07-09 |
| Device Manufacturer Date | 2019-02-21 |
| Date Added to Maude | 2019-05-29 |
| 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 | 2019-05-29 |
| Returned To Mfg | 2019-06-13 |
| Model Number | N/A |
| Catalog Number | WNSB-12-24 |
| Lot Number | NS9539988 |
| 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 | 2019-05-29 |