MalfunctionDSP
TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES
Received Jul 30, 2026 · Event occurred May 14, 2026
Report 2248146-2026-0001341 · MDR key 50078911
Device
Generic name
System, Balloon, Intra-aortic And Control
Manufacturer
Datascope Corp.Model number
0684-00-0608Catalog number
0684-00-0608
Lot number
3000446051
Product problems
- Positioning Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that, the Transray Plus 40cc Balloon Catheter malfunctioned. When attempting insertion, the included guidewire could not pass through the guidewire lumen. There was no patient harm reported. Procedure was performed by replacing this balloon catheter with one of the same type and size.
Additional Manufacturer Narrative
E. Initial ReporterEvent Site Postal Code: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.