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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEARTSTRING III PROXIMAL SEAL SYSTEM CLAMP VASCULAR

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MAQUET CARDIOVASCULAR LLC HEARTSTRING III PROXIMAL SEAL SYSTEM CLAMP VASCULAR Back to Search Results
Lot Number 25135907
Device Problem Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2018
Event Type  malfunction  
Event Description
Pt underwent cardiothoracic operative procedure, during which time a heartstring iii proximal seal system was utilized. The heartstring was not on the loader properly. A new heartstring was utilized and worked properly.
 
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Brand NameHEARTSTRING III PROXIMAL SEAL SYSTEM
Type of DeviceCLAMP VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
MDR Report Key7876575
MDR Text Key120455233
Report NumberMW5079813
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number25135907
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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