PERCOR STAT DL 9.5 FR. 40 CC IAB Adverse Event — Malfunction (MDR 100012)
PERCOR STAT DL 9.5 FR. 40 CC IAB Adverse Event — Malfunction (MDR 100012) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PERCOR STAT DL 9.5 FR. 40 CC IAB; Generic name: INTRA-AORTIC BALLOON CATHETER; Manufacturer: DATASCOPE CORP..
| Device | PERCOR STAT DL 9.5 FR. 40 CC IAB |
|---|---|
| Generic name | INTRA-AORTIC BALLOON CATHETER |
| Manufacturer | DATASCOPE CORP. |
| Report number | 100012 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 1997-06-17 |
| Narrative | THE IAB WAS INSERTED INTO THE PT'S 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 PERCUTANEOUSLY BECAUSE OF THE BALLOON RUPTURE. LATER IN THE DAY, THE PT REQUIRED REINSERTION OF ANOTHER IAB BECAUSE OF HE |
| Source | openFDA MAUDE (device adverse events) |
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