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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-035-090
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Date 09/16/2020
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 5mm sheath and 0. 035 guidewire during treatment of a 200mm calcified cto (chronic total occlusion-100%) in the patient¿s distal left superficial femoral artery (sfa) of diameter 6mm. Severe vessel calcification and tortuosity are reported. Ifu was followed. Vessel pre-dilation was not performed. It is reported that during removal of the catheter, the proximal portion of the catheter broke off in the very calcified subintimal vessel. The procedure was aborted, and the detached portion was left in the patient¿s subintimal portion of the sfa. 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 Key10552719
MDR Text Key207509884
Report Number2183870-2020-00300
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 10/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSC-035-090
Device Catalogue NumberSC-035-090
Device LOT NumberB013162
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 Received10/26/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/22/2020
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: 09/18/2020 Patient Sequence Number: 1
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