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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN TRAILBLAZER SUPPORT CATHETER CATHETER, PERCUTANEOUS

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COVIDIEN TRAILBLAZER SUPPORT CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number SC-018-135
Device Problem Device Damaged by Another Device (2915)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Physician intended to use a trailblazer support catheter with a 6fr non-medtronic sheath and 0. 018 nitrex wire during treatment of a 100mm cto (chronic total occlusion-100%) in the patient¿s mid left superficial femoral artery (sfa). Severe vessel tortuosity is reported. Artery diameter reported as 7mm. Ifu was followed. Damaged components related to the trailblazer device are reported during the procedure. It is reported the nitrex wire came out of the trailblazer proximal to the distal end of the catheter. No breaks are reported. The trailblazer was removed from the patient and replaced. No patient injury reported.

 
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Brand NameTRAILBLAZER SUPPORT CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10770069
MDR Text Key214125129
Report Number2183870-2020-00352
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK092299
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/14/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSC-018-135
Device Catalogue NumberSC-018-135
Device LOT NumberB058359
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/23/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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