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 5021 manufactured by Microvasive Endoscopy A Div Of Boston Scientific Corp..
[137296]
In was reported on 12/28/1998, that during an endoscopic retrograde cholangio-pancreatography procedure, the physician stated that he could not see the radiopaque markers on a passage dilator catheter and he subsequently perforated the pts' bile duct. A temporary stent was placed as intervention. No product was returned for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000048-1999-00014 |
| MDR Report Key | 239517 |
| Report Source | 05,06 |
| Date Received | 1999-09-01 |
| Date of Report | 1999-09-01 |
| Date of Event | 1998-12-21 |
| Device Manufacturer Date | 1998-07-01 |
| 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 |
| Model Number | NA |
| Catalog Number | 5021 |
| Lot Number | 1699962 |
| ID Number | NA |
| Device Expiration Date | 2001-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 232087 |
| Manufacturer | MICROVASIVE ENDOSCOPY A DIV OF BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US |
| Baseline Brand Name | PASSAGE BILIARY DILATATION CATHETER |
| Baseline Generic Name | DILATATION CATHETER |
| Baseline Catalog No | 5021 |
| 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 |