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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TRAPLINER CATHETER

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VASCULAR SOLUTIONS, LLC TRAPLINER CATHETER Back to Search Results
Model Number 5568
Device Problem Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2021
Event Type  Malfunction  
Manufacturer Narrative

A follow-up report will be issued after the investigation is complete.

 
Event Description

As reported: while trying to advance and retrieve the trapliner through the 8f inside a guide catheter to allocate the tip into the right rca (right coronary artery), it suddenly broke and disconnected. Thetrapliner was retrieved in the guide catheter and the procedure went on without trapliner. Patient outcome is reported as well, with no problems.

 
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Brand NameTRAPLINER
Type of DeviceCATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS, LLC
6464 sycamore court north
minneapolis MN 55369
Manufacturer (Section G)
VASCULAR SOLUTIONS, LLC
6464 sycamore court north
minneapolis MN 55369
Manufacturer Contact
mary haufek
6464 sycamore court north
minneapolis, MN 55369
7636564300
MDR Report Key11340661
MDR Text Key243926236
Report Number2134812-2021-00005
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK161901
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5568
Device LOT Number669470
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/01/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/18/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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