MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-01 for ARGON MEDICAL 190070 6FR-1.8MM 190070 manufactured by Maxxim Medical, Inc..
[21637078]
Bioptome jaws closure mechanism sprung apart leaving jaws open inside the heart. Could not close with handle. Finally closed by pulling on core wire with hemostat. Open jaws could not be extracted through sheath. This is the second such instrument failure in 10 day period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017093 |
| MDR Report Key | 238471 |
| Date Received | 1999-09-01 |
| Date of Report | 1999-08-23 |
| Date of Event | 1999-08-18 |
| Date Added to Maude | 1999-09-07 |
| 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 | ARGON MEDICAL |
| Generic Name | BIOPTOME |
| Product Code | DWZ |
| Date Received | 1999-09-01 |
| Returned To Mfg | 1999-08-18 |
| Model Number | 190070 6FR-1.8MM |
| Catalog Number | 190070 |
| Lot Number | 049907 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 231071 |
| Manufacturer | MAXXIM MEDICAL, INC. |
| Manufacturer Address | 1445 FLAT CREEK RD. ATHENS TX 75751 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-09-01 |