MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC HEARTSTRING; CLAMP, VASCULAR

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 05/21/2018

Event Type  malfunction  

Event Description

During use the aortic punch heartstring broke resulting in the punch extending further than normal.

• Brand Name: HEARTSTRING
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7600644
• MDR Text Key: 111046186
• Report Number: 7600644
• Device Sequence Number: 1
• Product Code: DXC
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Other Device ID Number: LOT# 25137394, 25137145, 2513
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR