System, Balloon, Intra-Aortic And Control
Received Jul 27, 2026
Report 2248146-2026-0001315 · MDR key 50004798
Device
Generic name
System, Balloon, Intra-aortic And Control
Manufacturer
Datascope Corp.Product problems
- Inflation Problem
- Obstruction of Flow
- Moisture or Humidity Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that during use, the Intra-Aortic Balloon (IAB) malfunctioned. "Low balloon pressure", "ballon blocked" and condensation in helium tubing were reported. No harm was reported. An evaluation was conducted by a Getinge Field Service Engineer (FSE) which revealed no faults were found with the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) which was in use with this balloon catheter at the time of the event.
Additional Manufacturer Narrative
E1 - Event Site Name: (b)(6). The lot number for the medical device referred to in this medical device report has not been received, and therefore, no UDI number can be provided.Upon completion of the investigation into this event a follow up report will be submitted.