• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTSTRING
Type of DeviceCLAMP, 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
Type of Report Initial
Report Date 06/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberLOT# 25137394, 25137145, 2513
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/06/2018
Event Location Hospital
Date Report to Manufacturer06/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-