GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL Adverse Event — Malfunction (MDR 2953148-2008-00162)
GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL Adverse Event — Malfunction (MDR 2953148-2008-00162) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL; Manufacturer: GUIDANT CARDIAC SURGERY; Report number: 2953148-2008-00162.
| Device | GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL |
|---|---|
| Manufacturer | GUIDANT CARDIAC SURGERY |
| Report number | 2953148-2008-00162 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, User facility, Company representation |
| Narrative | THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, FOUR HEARTSTRING SEALS DID NOT DEPLOY CORRECTLY OUT OF THE DELIVERY TUBE INTO THE AORTA. THE PROCEDURE WAS COMPLETED USING A SIDE CLAMP. NO PT COMPLICATIONS WERE REPORTED BY THE HOSP AS A RESULT. THIS REPORT IS FOR THE FIRST SEAL. |
| Source | openFDA MAUDE (device adverse events) |
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