MAUDE Adverse Event Report: MAQUET / DATASCOPE CORP. MAQUET IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number SENSATION 7FR 34CC

Device Problems Material Rupture (1546); Self-Activation or Keying (1557)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2019

Event Type  Injury  

Event Description

Pt with intra-aortic balloon pump, started to alarm and automatically switched to "stand by" mode.Line filled with blood.Pt had to have line pulled emergently.Upon examination, it was found the balloon had ruptured.Pt tolerated event well.Fda safety report id# (b)(4).

• Brand Name: MAQUET IABP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET / DATASCOPE CORP.
• MDR Report Key: 9226026
• MDR Text Key: 163754114
• Report Number: MW5090597
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SENSATION 7FR 34CC
• Device Lot Number: 30000876800273
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR