MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-29 for ACUCISE CATHETER B1005 * manufactured by Applied Medical, Urology Div..
[41723]
Physician inserted catheter to incise the right upj. When inflated and bovie cut to open the stricture, it was observed that the balloon improperly filled and was twisted on x-ray. Balloon appeared to be twisted around catheter. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010631 |
| MDR Report Key | 65435 |
| Date Received | 1997-01-29 |
| Date of Report | 1997-01-17 |
| Date of Event | 1997-01-13 |
| Date Added to Maude | 1997-01-31 |
| 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 | ACUCISE CATHETER |
| Generic Name | URETHROTOME |
| Product Code | EZO |
| Date Received | 1997-01-29 |
| Model Number | B1005 |
| Catalog Number | * |
| Lot Number | 96J045 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 65529 |
| Manufacturer | APPLIED MEDICAL, UROLOGY DIV. |
| Manufacturer Address | 26051 MERIT CIRCLE BLDG 104 LAGUNA HILLS CA 92653 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-29 |