MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR US SALES LLC / DATASCOPE CORP. INTRA AORTIC BALLON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0296-01U

Device Problem Material Rupture (1546)

Patient Problem Failure of Implant (1924)

Event Date 05/01/2021

Event Type  Injury  

Event Description

Pt awaiting oht, required placement of iabp for worsening cardiogenic shock.Right axillary iabp placed (b)(6) 2021; removed and replaced in left axillary (b)(6) 2021 due to iapb rupture.On (b)(6) 2021, left axillary iabp removed and replaced w/right femoral iabp due to iabp rupture.On (b)(6) 2021, pt underwent oht.Subsequently discharged for rehab.Fda safety report id # (b)(4).

• Brand Name: INTRA AORTIC BALLON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET CARDIOVASCULAR US SALES LLC / DATASCOPE CORP.
• MDR Report Key: 12438642
• MDR Text Key: 270800886
• Report Number: MW5103751
• Device Sequence Number: 1
• Product Code: DSP
• 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: 09/02/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0684-00-0296-01U
• Device Catalogue Number: 0684-00-0296-01U
• Device Lot Number: 3000140264
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR