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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 Problems Device Damaged by Another Device (2915); Separation Problem (4043)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2020
Event Type  Malfunction  
Manufacturer Narrative

Trapliner was returned to vsi/teleflex for evaluation. Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore supporting the device met material, assembly and performance specifications. Blood particulates were found along the length of the catheter. Separation of the half-pipe lumen from the hypotube push rod was noted. The collar transition had minor damage. No tip damage was observed. No other damage was noted on the catheter. A follow-up report will be issued after the investigation is complete.

 
Event Description

An email received from the customer reported that they had a case where they had a stent catch on the trapliner and the shaft broke away from the tubing. No further complications were reported.

 
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Brand NameTRAPLINER
Type of DeviceCATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS, LLC
6464 sycamore court north
minneaplois, mn
Manufacturer (Section G)
VASCULAR SOLUTIONS, LLC
6464 sycamore court north
minneaplois, mn
Manufacturer Contact
mary haufek
6464 sycamore court north
minneaplois, mn 
MDR Report Key10257704
MDR Text Key198348512
Report Number2134812-2020-00040
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5567
Device LOT Number668743
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/23/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/13/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/10/2020 Patient Sequence Number: 1
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