APEX MONORAIL Adverse Event — Injury (MDR 2134265-2008-00484)
APEX MONORAIL Adverse Event — Injury (MDR 2134265-2008-00484) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: APEX MONORAIL; Generic name: PTCA DILATATION CATHETER; Manufacturer: BOSTON SCIENTIFIC.
| Device | APEX MONORAIL |
|---|---|
| Generic name | PTCA DILATATION CATHETER |
| Manufacturer | BOSTON SCIENTIFIC |
| Report number | 2134265-2008-00484 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2008-02-19 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE AND A VESSEL RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED DISTAL LEFT CIRCUMFLEX (LCX). A NON BSC GUIDE WIRE WAS ADVANCED TO THE LESION AND WAS PREDILATED BY A 1.5MM APEX BALLOON. THE PHYSICIAN THEN CHANGED THE APEX BALLOON TO A 2.00X12MM APEX BALLO |
| Source | openFDA MAUDE (device adverse events) |
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