MAVERICK2 MONORAIL PTCA CATHETER Adverse Event — Malfunction (MDR 2134265-2008-00447)
MAVERICK2 MONORAIL PTCA CATHETER Adverse Event — Malfunction (MDR 2134265-2008-00447) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MAVERICK2 MONORAIL PTCA CATHETER; Generic name: LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO; Manufacturer: BOSTON SCIENTIFIC.
| Device | MAVERICK2 MONORAIL PTCA CATHETER |
|---|---|
| Generic name | LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO |
| Manufacturer | BOSTON SCIENTIFIC |
| Report number | 2134265-2008-00447 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND 90% STENOTIC MID RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED THE 2.5X20MM MAVERICK2 BALLOON TO THE LESION AND INFLATED IT TO 4 ATMS ON THE FIRST INFLATION AND IT RUPTURED. THERE WERE NO PT COMPLICATIONS. THE PROCEDURE WAS SUCCESSF |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →