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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 5567
Device Problem Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2020
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing records were reviewed, and there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications. A returned product evaluation was completed. The trapliner shaft was separated at the weld joint. No other damage was found. The failure was likely caused by mishandling the device. The ifu warns: "exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage or kinking. " the most likely root cause for the separation was operational context and unintended user error.

 
Event Description

As reported: using a 7f trapliner for a cto. Physician was advancing the catheter over the wire (still outside of the body) the tube broke off from the shaft. There was no harm to the patient and the problem was fixed by opening a new trapliner. The scrubber didn't notice any issues while prepping the device. Attempts were made to return the device for investigation. After return of the device, and images taken (b)(6) 2020 it was determined what the actual "tube broke" was a separation at the weld joint of the catheter. The device was not used in patient.

 
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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 Key10896163
MDR Text Key226855411
Report Number2134812-2020-00095
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
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
Report Date 10/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5567
Device LOT Number672348
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/07/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/14/2020
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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