MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-31 for ABBOTT CRITICAL CARE 41223-01 manufactured by Abbott Critical Care.
[20770792]
During the performance of a right heart catherization procedure, the balloon failed to deflate. Malfunction was noticed as the physician was attempting to re-position the catheter. Negative and positive pressure was applied (via syringe) in an attempt to deflate the balloon. The balloon detached as the catheter was being removed. Removal procedure attempted on 8/5/93, but was unsuccessfuldevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure, balloon. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6367 |
| MDR Report Key | 6367 |
| Date Received | 1993-08-31 |
| Date of Report | 1993-08-05 |
| Date of Event | 1993-07-29 |
| Date Facility Aware | 1993-07-29 |
| Report Date | 1993-08-05 |
| Date Reported to FDA | 1993-08-05 |
| Date Reported to Mfgr | 1993-07-29 |
| Date Added to Maude | 1993-09-01 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT CRITICAL CARE |
| Generic Name | TRIPLE LUMEN CATHETER |
| Product Code | GBP |
| Date Received | 1993-08-31 |
| Model Number | 41223-01 |
| Catalog Number | 41223-01 |
| Lot Number | 71-030-SN01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6056 |
| Manufacturer | ABBOTT CRITICAL CARE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-08-31 |