MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-07 for RIGIFLEX TTS ANASTOMATIC BALLOON CATHETER 5532 manufactured by Boston Scientific Corp..
[8428]
Pt scheduled for outpatient colonoscopy. The 75 french pneumatic dilator was primed and tested prior to the start of the procedure. The procedure started at 11:47 am. When the balloon was inflated during the procedure, it ruptured. The procedure ended at 12/17 pm. The pt developed abdominal distention and discomfort. Flat plate and lateral decubitus x-rays of abdomen completed. At 1:25 pm pt was taken to the or for exploratory laparotomy and repair of colonic perforation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 13062 |
| MDR Report Key | 13062 |
| Date Received | 1994-02-07 |
| Date of Report | 1994-02-07 |
| Date of Event | 1994-01-31 |
| Date Facility Aware | 1994-01-31 |
| Report Date | 1994-02-07 |
| Date Added to Maude | 1994-05-04 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIGIFLEX TTS ANASTOMATIC BALLOON CATHETER |
| Product Code | FFP |
| Date Received | 1994-02-07 |
| Returned To Mfg | 1994-02-04 |
| Model Number | TTS |
| Catalog Number | 5532 |
| Lot Number | 89828 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13060 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | WATERTOWN MA 02172 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1994-02-07 |