MAUDE Adverse Event Report: MARQUET MEDICAL / DATASCOPE CORP. SENSATION PLUS 8 FR.; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 09/14/2021

Event Type  Injury  

Event Description

There was a failure of a balloon pump.The catheter alarmed and there was blood in the catheter tubing.The patient was brought to the cath lab for removal of the defected catheter and implant of a new iabp in the opposite groin.Fda safety report id# (b)(4).

• Brand Name: SENSATION PLUS 8 FR.
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MARQUET MEDICAL / DATASCOPE CORP.
• MDR Report Key: 12482144
• MDR Text Key: 272473765
• Report Number: MW5104029
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 104