MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2005-06-02 for .035" BACK-UP MEIER STEERABLE GUIDE WIRE H965SCH306001 manufactured by Boston Scientific.
[399517]
It was reported that during a diagnostic procedure, the tip of the meier guide wire fractured inside the patient. The physician was able to remove the fractured portion with a biopsy forceps. Additional information regarding this complaint has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000130-2005-00347 |
| MDR Report Key | 610610 |
| Report Source | 01,05,07 |
| Date Received | 2005-06-02 |
| Date of Report | 2005-05-03 |
| Date of Event | 2005-04-19 |
| Date Mfgr Received | 2005-05-03 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2005-06-07 |
| 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 | ON 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 | .035" BACK-UP MEIER STEERABLE GUIDE WIRE |
| Generic Name | PTA GUIDE WIRE |
| Product Code | DQH |
| Date Received | 2005-06-02 |
| Returned To Mfg | 2005-06-21 |
| Model Number | NA |
| Catalog Number | H965SCH306001 |
| Lot Number | 6723269 |
| ID Number | NA |
| Device Expiration Date | 2006-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 600404 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 8600 NW 41ST STREET MIAMI FL 331666202 US |
| Baseline Brand Name | .035" BACK-UP MEIER STEERABLE GUIDE WIRE |
| Baseline Generic Name | PTA GUIDE WIRE |
| Baseline Model No | NA |
| Baseline Catalog No | H965SCH306001 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-06-02 |