ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHIL Adverse Event — Malfunction (MDR 2024168-2008-00110)
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHIL Adverse Event — Malfunction (MDR 2024168-2008-00110) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHIL; Generic name: 74DQX; Manufacturer:
| Device | ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHIL |
|---|---|
| Generic name | 74DQX |
| Manufacturer | ABBOTT VASCULAR-CARDIAC THERAPIES |
| Report number | 2024168-2008-00110 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-14 |
| Report source | Foreign, Company representation |
| Narrative | REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: SEPARATED GUIDE WIRE COULD CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT DURING INSERTION INTO THE GUIDING CATHETER, THE GUIDE WIRE WAS FOUND DISTORTED AND THE HYDROCOAT HAD COME OFF. THE GUIDE WIRE WAS REMOVED AND REPLACED WITH ANOTHER BMW GUIDE WIRE AND THE PROCEDURE WAS COMPLETED SATISFACTORIL |
| Source | openFDA MAUDE (device adverse events) |
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