PERCOR STAT D. 9.5 FR. 40 CC IAB Adverse Event — Malfunction (MDR 2248146-1997-00634)
PERCOR STAT D. 9.5 FR. 40 CC IAB Adverse Event — Malfunction (MDR 2248146-1997-00634) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PERCOR STAT D. 9.5 FR. 40 CC IAB; Generic name: *; Manufacturer: *.
| Device | PERCOR STAT D. 9.5 FR. 40 CC IAB |
|---|---|
| Generic name | * |
| Manufacturer | * |
| Report number | 2248146-1997-00634 |
| Event type | Malfunction |
| Date received | 1997-06-17 |
| Report source | User facility |
| Narrative | THE IAB WAS INSERTED INTO THE PT LEFT FEMORAL ARTERY ON 5/31/97 BECAUSE OF CHEST PAIN WITH DOCUMENTED THREE VESSEL CAD. THE PT WENT FOR CABG X4 ON 6/1/97. IN THE EARLY AM ON 6/3/97, BLOOD WAS NOTED IN THE TUBING FROM THE CATHETER. THE BALLOON CATHETER AND SHEATHS WERE REMOVED PERCUTANEOUSY BECAUSE OF THE BALLOON RUPTURE. LATER IN THE DAY, THE PT REQUIRED REINSERTION OF ANOTHER IAB BECAUSE OF HEMOD |
| Source | openFDA MAUDE (device adverse events) |
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