MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC SENSATION IAB CATHETER; SYSTEM, BALLOON, INTRA-AORTIC

Device Problems Material Rupture (1546); Device Displays Incorrect Message (2591)

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

Event Date 07/17/2016

Event Type  malfunction  

Event Description

Iab console alarmed for "blood detected" or "rapid gas loss".Iab catheter rupture caused about 50 cc of helium to be released into patient's aorta.Concern that the gas could act as an embolis.

• Brand Name: SENSATION IAB CATHETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 5932086
• MDR Text Key: 54040811
• Report Number: 5932086
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR