MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-18 for INSITUCAR (R) VALVULOTOME 5521114 manufactured by Braun Medical.
[9284]
During a surgical procedure, the insitucat valvulotome tip came off in situ. The tip was extracted through a surrgical incision. Another insitucat device was obtained aaaaand the procedure was completed without further complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-1994-00004 |
| MDR Report Key | 14326 |
| Date Received | 1994-03-18 |
| Date of Report | 1994-03-02 |
| Date of Event | 1994-02-15 |
| Date Facility Aware | 1994-02-15 |
| Report Date | 1994-03-02 |
| Date Reported to FDA | 1994-03-02 |
| Date Reported to Mfgr | 1994-03-03 |
| Date Added to Maude | 1994-06-27 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | INSITUCAR (R) VALVULOTOME |
| Generic Name | VALVE CUTTER |
| Product Code | HAM |
| Date Received | 1994-03-18 |
| Model Number | NA |
| Catalog Number | 5521114 |
| Lot Number | 2/3084 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14322 |
| Manufacturer | BRAUN MEDICAL |
| Manufacturer Address | 34212 MELSUGNGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-03-18 |