MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2005-05-26 for T-REX BIOPSY FORCEPS T-REX BIOPSY FORCEPS 50CM 2.2MM PRE-CRV H749234670010 manufactured by Boston Scientific.
[398734]
Duirng a biopsy procedure, the forceps broke. The physician was attempting to do a biopsy in the ventricle of a heart transplant recipient to check tissue health when the forceps broke. The device was exchanged and the procedure was successfully completed with another forceps. No pt injuries or complications occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000130-2005-00341 |
| MDR Report Key | 611107 |
| Report Source | 04,06 |
| Date Received | 2005-05-26 |
| Date of Report | 2005-04-27 |
| Date of Event | 2005-04-25 |
| Date Mfgr Received | 2005-04-27 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2005-06-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE GUDITH - MS B240 |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 553111566 |
| Manufacturer Country | US |
| Manufacturer Postal | 553111566 |
| Manufacturer Phone | 7634941194 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-REX BIOPSY FORCEPS |
| Generic Name | BIOPSY FORCEPS |
| Product Code | DWZ |
| Date Received | 2005-05-26 |
| Returned To Mfg | 2005-05-16 |
| Model Number | T-REX BIOPSY FORCEPS 50CM 2.2MM PRE-CRV |
| Catalog Number | H749234670010 |
| Lot Number | 7492414 |
| ID Number | NA |
| Device Expiration Date | 2008-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 600901 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 8600 NW 41ST STREET MIAMI FL 331666202 US |
| Baseline Brand Name | T-REX BIOPSY FORCEPS |
| Baseline Generic Name | BIOPSY FORCEPS |
| Baseline Model No | T-REX BIOPSY FO |
| Baseline Catalog No | H749234670010 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-26 |