MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) ARROW IABP (INTRA-AORTIC BALLOON PUMP); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number IAB-05850-LWS

Patient Problem Hematoma (1884)

Event Date 09/02/2023

Event Type  Injury  

Event Description

Abp (intra-aortic balloon pump) was inserted into a stemi (st-segment elevation myocardial infarction) patient.Iabp alarmed and never fully inflated.Iabp was removed and patient ended up with a massive hematoma.Hemostasis was eventually achieved and patient was transferred to cvicu (cardiovascular intensive care unit).But was not able to receive the benefits from the iabp.

• Brand Name: ARROW IABP (INTRA-AORTIC BALLOON PUMP)
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)
• MDR Report Key: 17720265
• MDR Text Key: 323180553
• Report Number: MW5145467
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05850-LWS
• Device Lot Number: 18F22J0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White