MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 1998-11-12 for QUANTUM BILIARY DILATION CATHETER Q8D-8X3 manufactured by Wilson-cook Medical.
[119308]
The physician dilated the papilla prior to a gallstone removal using a biliary dilation catheter. During the stone removal the catheter severed and the balloon ruptured. The distal tip of the catheter was immediately retrieved. It was noticed that the papilla was torn and the pt was bleeding heavily. The bleeding was stopped with the injection of suprarenin. An endoscopy was performed as a control and after one day showing that the bleeding had stopped and that no perforation had occurred. In the meanwhile the pt was discharged from the hosp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-1998-00041 |
| MDR Report Key | 196296 |
| Report Source | 05,08 |
| Date Received | 1998-11-12 |
| Date of Report | 1998-10-16 |
| Date of Event | 1998-10-14 |
| Date Mfgr Received | 1998-10-16 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 1998-11-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUANTUM BILIARY DILATION CATHETER |
| Generic Name | DILATION CATHETER |
| Product Code | FGF |
| Date Received | 1998-11-12 |
| Returned To Mfg | 1998-10-30 |
| Model Number | NA |
| Catalog Number | Q8D-8X3 |
| Lot Number | 1119616 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 190710 |
| Manufacturer | WILSON-COOK MEDICAL |
| Manufacturer Address | 4900 BETHANIA STATION RD. WINSTON-SALEM NC 27105 US |
| Baseline Brand Name | QUANTUM BILIARY DILATION CATHETER |
| Baseline Generic Name | DILATION CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | Q8D-8X3 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-11-12 |