MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2004-01-09 for COTTON LEUNG BILIARY CLBS-10-5 manufactured by Wilson-cook Medical, Inc..
[16819932]
The physician removed multiple wilson-cook cotton leung biliary stents in a stent exchange procedure. Three months after stent placement two of three stents were removed successfully using a minisnare. Resistance was encountered while trying to remove the third stent from the pt's duct. This difficulty resulted in the minisnare fracturing the distal end of the stent as it was removed. An ercp procedure revealed a fragment of the stent in the pt's duct. After an unsuccessful attempt to remove the fragment with a retrieval basket the physician decided to leave the fragment in place with continued stent exchanges at three month intervals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2004-00005 |
| MDR Report Key | 508914 |
| Report Source | 06,08 |
| Date Received | 2004-01-09 |
| Date of Report | 2003-12-09 |
| Date Mfgr Received | 2003-12-09 |
| Date Added to Maude | 2004-02-02 |
| 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 | 0 |
| Manufacturer Contact | JESSICA HUGHES, MANAGER |
| Manufacturer Street | 4900 BETHANIA STATION ROAD |
| Manufacturer City | WINSTON SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COTTON LEUNG BILIARY |
| Generic Name | BILIARY STENTS |
| Product Code | IGE |
| Date Received | 2004-01-09 |
| Model Number | NA |
| Catalog Number | CLBS-10-5 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 497864 |
| Manufacturer | WILSON-COOK MEDICAL, INC. |
| Manufacturer Address | 4900 BETHANIA STATION RD. WINSTON SALEM NC 27105 US |
| Baseline Brand Name | COTTON LEUNG BILIARY |
| Baseline Generic Name | RILIARY STENTS |
| Baseline Model No | NA |
| Baseline Catalog No | CLBS-10-5 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-01-09 |