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 2019-05-24 for COMMON BILE DUCT EXPLORATION SET N/A C-CDES-100 manufactured by Cook Inc.
[146044285]
Initial reporter also sent report to fda: unknown. Pma/510(k) #: not exempt, preamendment. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146044286]
It was reported the basket of a common bile duct exploration set broke during a laparoscopic common bile duct (cbd) procedure. The physician was performing a laparoscopic procedure to retrieve multiple stones from the patient's common bile duct. Upon attempted removal of the stone, the basket broke off of the tip of the catheter. Reinsertion and attempts to retrieve the basket were unsuccessful, as the basket was swept into the duodenum. In additional information received, the patient required an endoscopic retrograde cholangiopancreatography (ercp) for completion of stone and debris removal. A cholangioscopy performed at the time found no evidence of retained basket in the patient. As reported, there have been no adverse effects experienced by the patient due to this occurrence. The device will not be returned for investigation, as it was discarded by the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01239 |
| MDR Report Key | 8639649 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-24 |
| Date of Report | 2019-07-01 |
| Date of Event | 2019-05-05 |
| Date Mfgr Received | 2019-06-11 |
| Date Added to Maude | 2019-05-24 |
| 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 | COMMON BILE DUCT EXPLORATION SET |
| Generic Name | LQR DISLODGER, STONE BILIARY |
| Product Code | LQR |
| Date Received | 2019-05-24 |
| Model Number | N/A |
| Catalog Number | C-CDES-100 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2019-05-24 |