MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-20 for WITTICH NITINOL STONE BASKET WNSB-12-24 manufactured by Cook Inc.
[137560966]
Common name: dislodger, stone, biliary. Pro code: lqr. Pma/510k #: k902944. Investigation? Evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation. The visual inspection of the returned device confirmed that the proximal hub (cap and adaptor) separated from the sheath material. A crease within the flare was noted, indicating the sheath material was caught between the cap and adaptor. Additionally, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. A review of the device history record showed the lot was released meeting all finished goods release criteria. It should be noted there was one other reported complaint for this lot number. Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established. Per the quality engineering risk assessment no further action is required. Cook will continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[137560967]
It was originally reported that the device valve separated from the catheter when the operator tried to pull the biliary stone out. No patient adverse events resulted from the malfunctioning of the device, and the complaint device was exchanged for a new device with no consequences for the patient. It was later discovered during the investigation of the returned device that it was the hub of the device which separated from the sheath material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00456 |
| MDR Report Key | 8354629 |
| Date Received | 2019-02-20 |
| Date of Report | 2019-02-20 |
| Date of Event | 2018-11-20 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2017-11-10 |
| Date Added to Maude | 2019-02-20 |
| 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 | 0 |
| Brand Name | WITTICH NITINOL STONE BASKET |
| Product Code | LQR |
| Date Received | 2019-02-20 |
| Returned To Mfg | 2018-12-07 |
| Catalog Number | WNSB-12-24 |
| Lot Number | 8366076 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-02-20 |