MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2005-05-27 for PASSAGE BILIARY DILATION CATHETER 5020 manufactured by Boston Scientific Corp..
[370939]
The complainant reported that the physician was performing a therapeutic dilation of a pt's (age and gender unk) biliary duct, but the during the procedure the distal portion of the dilation plug broke off in the pt's biliary duct. It was indicated that the detached section of the device was successfully removed by the doctor with the aid of a basket device. The procedure was then halted and rescheduled for another date. The complainant indicated that there was no adverse affect to the pt as a result of the reported malfunction and that the pt is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000048-2005-00072 |
| MDR Report Key | 612347 |
| Report Source | 01,05,06,07 |
| Date Received | 2005-05-27 |
| Date of Report | 2005-04-11 |
| Date of Event | 2005-04-11 |
| Date Mfgr Received | 2005-05-11 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2005-06-13 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086834066 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASSAGE BILIARY DILATION CATHETER |
| Generic Name | DILATATION CATHETER |
| Product Code | GCC |
| Date Received | 2005-05-27 |
| Returned To Mfg | 2005-05-03 |
| Model Number | NA |
| Catalog Number | 5020 |
| Lot Number | 49033320 |
| ID Number | NA |
| Device Expiration Date | 2005-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 602175 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 780 BROOKSIDE DR. SPENCER IN 47460 US |
| Baseline Brand Name | PASSAGE BILIARY DILATION CATHETER |
| Baseline Generic Name | DILATATION CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 5020 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-27 |