MAUDE Adverse Event Report: MAQUET SENSATION BALLOON CATHETER

Catalog Number 0684-00-0469-01U

Device Problem Leak/Splash (1354)

Patient Problems Death (1802); No Code Available (3191)

Event Date 05/28/2016

Event Type  Injury  

Event Description

Intraaortic balloon pump catheter noted to have balloon malfunction (leak) while in use on patient with post stemi acute hemodynamic collapse.Balloon changed out and second balloon functioned as designed.Patient subsequently expired on (b)(6) 2016 after post stemi development of ventricular septal defect and akinetic right ventricle.

• Brand Name: SENSATION BALLOON CATHETER
• Type of Device: SENSATION BALLOON CATHETER
• Manufacturer (Section D): MAQUET; fairfield NJ 07004
• MDR Report Key: 5697762
• MDR Text Key: 46568962
• Report Number: MW5062614
• 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: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/13/2018
• Device Catalogue Number: 0684-00-0469-01U
• Device Lot Number: 3000016155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Weight: 87