MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-09-01 for PASSAGE BILIARY DILATATION CATHETER 5020 manufactured by Microvasive Endoscopy A Div Of Boston Scientific Corp..
[137294]
It was reported on 12/28/1998 that during an endoscopic retrograde cholangio-pancreatography procedure, the physician could not see the radiopaque markers on a passage biliary dilation catheter and subsequently perforated the pts bile duct. The product was not returned for eval. An eval of the device revealed that twenty percent of the radiopaque markers were missing and possibly rubbed off of the device. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000048-1999-00013 |
| MDR Report Key | 239506 |
| Report Source | 05,06 |
| Date Received | 1999-09-01 |
| Date of Report | 1999-09-01 |
| Date of Event | 1998-12-21 |
| Date Mfgr Received | 1999-01-06 |
| Device Manufacturer Date | 1998-08-01 |
| Date Added to Maude | 1999-09-14 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASSAGE BILIARY DILATATION CATHETER |
| Generic Name | DILATATION CATHETER |
| Product Code | GCC |
| Date Received | 1999-09-01 |
| Returned To Mfg | 1999-01-06 |
| Model Number | NA |
| Catalog Number | 5020 |
| Lot Number | 1796777 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 232076 |
| Manufacturer | MICROVASIVE ENDOSCOPY A DIV OF BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 780 BROOKSIDE DR SPENCER IN 47460 US |
| Baseline Brand Name | PASSAGE BILIARY DILATATION CATHETER |
| Baseline Generic Name | DILATATION CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 5020 ET. AL |
| Baseline Device Family | DILATATION CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K833417 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-09-01 |