MAUDE Adverse Event Report: GETINGE USA SALES LLC / DATASCOPE CORP MAQUET IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number 3000113810

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2020

Event Type  malfunction  

Event Description

After log rolling pt, blood noted in helium line of iabp.Iabp placed on standby then turned off.Pt returned to cath lab for new iabp.Balloon ruptured.Etiology of ruptured balloon unknown at this time.Balloon returned to manufacturer.Fda safety report id# (b)(4).

• Brand Name: MAQUET IABP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): GETINGE USA SALES LLC / DATASCOPE CORP
• MDR Report Key: 10546455
• MDR Text Key: 207606460
• Report Number: MW5096709
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3000113810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 88 YR