MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-02 for HYDROSTATIC BALLOON DILATOR manufactured by Boston Scientific Corp..
[18572]
During the balloon dilation phase of ercp, there was a sudden leak in the balloon with extravasation of sterile saline into the dorsal duct. Pt developed acute pancreatitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009001 |
| MDR Report Key | 32515 |
| Date Received | 1996-05-02 |
| Date of Report | 1996-04-09 |
| Date of Event | 1996-02-29 |
| Date Added to Maude | 1996-05-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDROSTATIC BALLOON DILATOR |
| Generic Name | VESSEL DILATOR |
| Product Code | FKA |
| Date Received | 1996-05-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33795 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | RT 9 NATTICK MA 01760 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 1996-05-02 |