MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR AVALON CLITE 31FR. CANNULA; ECMO CANNULA

Catalog Number 10031

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Exsanguination (1841); Atrial Perforation (2511)

Event Date 01/07/2015

Event Type  Death  

Event Description

Right atrial tear noted during attempted insertion of cannula for venous-venous ecmo in operating room on (b)(6) 2015.Repair of atrial tear performed.Pt expired on (b)(6) 2015.

• Brand Name: AVALON CLITE 31FR. CANNULA
• Type of Device: ECMO CANNULA
• Manufacturer (Section D): MAQUET CARDIOVASCULAR; wayne NJ
• MDR Report Key: 4462365
• MDR Text Key: 5321145
• Report Number: MW5040413
• Device Sequence Number: 1
• Product Code: DWF
• 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: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10031
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 53 YR