MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number 3000069363

Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2020

Event Type  malfunction  

Event Description

The information reported was that the inner lumen of the micro puncture sheath had a device failure and sheared with iabp attempt.It is reported that it developed a puncture as it was being inserted.When the device failed, the patient was brought back to the cath lab and the balloon replaced.The entire system was removed and not retained in the body.

• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond rd; wayne NJ 07470
• MDR Report Key: 10902666
• MDR Text Key: 218195648
• Report Number: 10902666
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/25/2020,08/31/2020

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 Lot Number: 3000069363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 134