MAUDE Adverse Event Report: GETINGE /DATASCOPE CORP. MAQUET 7.5F 40CC MEGA INTRA-AORTIC BALLOON INSERTION KIT & SHEATH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 068400029501U

Device Problem Use of Device Problem (1670)

Patient Problems Cardiac Arrest (1762); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/13/2023

Event Type  Injury  

Event Description

While patient was in intensive care unit blood was noted in the intra-aortic balloon pump helium line, which had been in place for 23 hours, requiring immediate shut off of device.Patient suffered cardiac arrest leading to thrombosis, inadequate perfusion, family decision to place on comfort care, and death.

• Brand Name: MAQUET 7.5F 40CC MEGA INTRA-AORTIC BALLOON INSERTION KIT & SHEATH
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): GETINGE /DATASCOPE CORP.
• MDR Report Key: 16818287
• MDR Text Key: 314116516
• Report Number: MW5117071
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 068400029501U
• Device Lot Number: 3000301412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White