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U.S. Department of Health and Human Services

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

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MAQUET CARDIOVASCULAR, LLC HEARTSTRING; CLAMP, VASCULAR Back to Search Results
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.
 
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Brand Name
HEARTSTRING
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR, LLC
45 barbour pond drive
wayne NJ 07470
MDR Report Key7600644
MDR Text Key111046186
Report Number7600644
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberLOT# 25137394, 25137145, 2513
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/06/2018
Event Location Hospital
Date Report to Manufacturer06/06/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age56 YR
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