MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-20 for BALLOON CATHETER 5145 manufactured by Microvasive Endoscopy Div. Boston Scientific Corp..
[21247861]
During procedure balloon burst and remained in the pt. A second catheter was used and the balloon piece was observed in the duodenum, passed naturally. No pt harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004823 |
| MDR Report Key | 19071 |
| Date Received | 1995-01-20 |
| Date of Report | 1995-01-09 |
| Date of Event | 1994-12-26 |
| Date Added to Maude | 1995-01-23 |
| 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 |
| 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 | BALLOON CATHETER |
| Generic Name | CATHETER, ESOPHAGEAL, BALLOON |
| Product Code | KCF |
| Date Received | 1995-01-20 |
| Catalog Number | 5145 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18997 |
| Manufacturer | MICROVASIVE ENDOSCOPY DIV. BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | WATERTOWN MA 02172 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-01-20 |