MalfunctionPDU
PIONEER PLUS
Received Jul 30, 2021
Report MW5102904 · MDR key 12260274
Device
Generic name
Catheter For Crossing Total Occlusions
Manufacturer
Medtronic Inc. / Volcano CorporationModel number
PPLUS120Lot number
5042159
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
TIP OF CATHETER FELL OFF PRIOR TO INSERTION INTO PATIENT. FDA SAFETY REPORT ID # (B)(4).