SLALOM PTA .018 HP 40 5X4 Adverse Event — Malfunction (MDR 9616099-2020-03671)
SLALOM PTA .018 HP 40 5X4 Adverse Event — Malfunction (MDR 9616099-2020-03671) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SLALOM PTA .018 HP 40 5X4; Generic name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL; Manufacturer: CORDIS CORPORATION.
| Device | SLALOM PTA .018 HP 40 5X4 |
|---|---|
| Generic name | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
| Manufacturer | CORDIS CORPORATION |
| Report number | 9616099-2020-03671 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | COMPLAINT CONCLUSION: DURING A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, THE BALLOON OF A 40MM 5X4 SLALOM PTA HIGH-PRESSURE DILATATION CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE AFTER IT WAS DELIVERED TO THE ANASTOMOTIC PARTS OF THE VESSEL AND INFLATED THE TWO LESIONS. HOWEVER, AFTER THE INFLATION IT MADE THE STENOSIS LOOKS SMALLER AS CONFIRMED BY ANGIOGRAPHY. THE DEVICE WAS |
| Source | openFDA MAUDE (device adverse events) |
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