FDA Adverse Event
Malfunction
Summary report: N
INTRAORTIC BALLOON PUMP CATHETER
MDR report key: 19537553
·
Received June 13, 2024
Report
- Report Number
- MW5156262
- Event Type
- Malfunction
- Date Received
- June 13, 2024
- Date of Event
- May 29, 2024
- Report Date
- June 11, 2024
- Manufacturer
- ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- ND, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT UNDERWENT EMERGENCY CABGX2 WITH INTRA-AORTIC BALLOON PUMP (IABP) ON (B)(6) 2024. ON (B)(6) 2024, THE NURSE NOTICED BLOOD IN THE HELIUM TUBE OF THE BALLOON PUMP CATHETER. THE PROVIDER WAS NOTIFIED IMMEDIATELY AND THE IABP WAS REMOVED DUE TO COMPLICATIONS AND PER RECOMMENDATIONS OF A RECENT URGENT MEDICAL DEVICE NOTIFICATION FROM ARROW INTERNATIONAL LLC REGARDING THIS PRODUCT. THE PATIENT WAS ABLE TO BE MANAGED CLINICALLY WITHOUT SIGNIFICANT CLINICAL INTERVENTION. THIS EVENT WAS REPORTED TO THE VENDOR 5/31/2024 AND THE PRODUCT WAS RETURNED TO THE VENDOR 6/10/2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1687943 | INTRAORTIC BALLOON PUMP CATHETER | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) | AY30696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Other |