MAUDE Adverse Event Report: MAQUET / DATASCOPE CORP. SENSATION PLUS FIBER-OPTIC IAB CATHETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 7.5 FR. 40CC

Device Problem Defective Component (2292)

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

Event Date 04/05/2022

Event Type  malfunction  

Event Description

After inserting a 7.5 fr 40 cc balloon pump, the console displayed a trigger error due to a defective fiber optic cable.Fda safety report id # (b)(4).

• Brand Name: SENSATION PLUS FIBER-OPTIC IAB CATHETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET / DATASCOPE CORP.
• MDR Report Key: 14074422
• MDR Text Key: 289188475
• Report Number: MW5108867
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Model Number: 7.5 FR. 40CC
• Device Lot Number: 3000111682
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1