FDA Adverse Event
Malfunction
Summary report: N
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
MDR report key: 25043410
·
Received April 30, 2026
Report
- Report Number
- 2249723-2026-0002496
- Event Type
- Malfunction
- Date Received
- April 30, 2026
- Date of Event
- April 7, 2026
- Report Date
- May 15, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CONCOMITANT PRODUCTS: TRANSRAY PLUS 35CC OT#1508025 ZEON CORPORATION, 8FR 35CC OT#1508025. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT WHILE USING AN UNKNOWN INTRA AORTIC BALLOON PUMP (IABP) THE BALLOON DID NOT EXPAND PROPERLY. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 365866 | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |