MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED) INTRA-AORTIC BALLOON KIT 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number 18F22J0040

Patient Problem Hematoma (1884)

Event Date 09/02/2023

Event Type  Injury  

Event Description

Iabp (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: INTRA-AORTIC BALLOON KIT 50CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED); morrisville NC 2756
• MDR Report Key: 17728885
• MDR Text Key: 323298107
• Report Number: MW5145539
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Lot Number: 18F22J0040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 143 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White