InjuryLOX
PTCA DILATION CATHETER
Received Jul 14, 2022 · Event occurred Jul 12, 2022
Report MW5110892 · MDR key 15028585
Device
Generic name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Model number
H7493895912150Lot number
28242516
Product problems
- Detachment of Device or Device Component
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
USING FLEX BALLOON DURING HEART CATHETERIZATION, BALLOON CATHETER WAS DETACHED FROM WIRED AND REMAINED IN BODY WITH BALLOON STILL INFLATED. FDA SAFETY REPORT ID# (B)(4).