FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIE Adverse Event — Malfunction (MDR 3005334138-2020-00172)
FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIE Adverse Event — Malfunction (MDR 3005334138-2020-00172) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIE; Generic name: INTRODUCER, CATHET
| Device | FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIE |
|---|---|
| Generic name | INTRODUCER, CATHETER |
| Manufacturer | ST. JUDE MEDICAL |
| Report number | 3005334138-2020-00172 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE REPORTED EVENT OF A LEAK WAS CONFIRMED. A LEAK WAS NOTED AT THE HEMOSTASIS VALVE DURING FUNCTIONAL TESTING. THE CAP WAS REMOVED FROM THE HEMOSTASIS HUB AND THE HEMOSTASIS SEAL WAS MICROSCOPICALLY INSPECTED. TEARING, RESULTING IN A HOLE, WAS NOTED ON THE SEAL. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE TORN S |
| Source | openFDA MAUDE (device adverse events) |
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