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

Catalog Number	SC-035-090
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It is reported that while using the trailblazer catheter for an unknown procedure, an intra-arterial rupture of the probe occured.This lead to the procedure being abandoned plus intervention was required to retrieve the catheter.
Additional Manufacturer Narrative
A trailblazer device has been used in treatment of the patients right external iliac artery.Access was through the left common femoral artery.It is reported that a section of the trailblazer probe segmented and migrated into the right afs during the change of the guide.The component embolized in the patient and had to be retrieved by use of a snare.The procedure was aborted at this point.The patient is reported to be doing well following the procedure.No patient injury reported.Returned device analysis summary: the trailblazer catheter was received for evaluation.No ancillary devices, procedural reports, or cine images from the procedure were received.The trailblazer catheter was received in two segments: all components of the trailblazer catheter were accounted for.The distal segment contained all three radiopaque marker bands.The distal segment has several bends that gave it an undulated appearance.A kink in the catheter was located just proximal of the proximal marker band.The kink is consistent with that of a distal catheter segment being snared or being removed with forceps.The proximal end of the distal segment exhibited torsional and tensile stretching at the separation face.The proximal segment distal end exhibited a mirror image of the proximal end of the distal segment; indicated that all components were accounted for.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Target treatment vessel: - right external/ primary iliac artery - severe tortuosity reported.- the vessel was not pre or post dilated.Ancillary devices used: - 0,35" 90cm sheath - 0,35" 260cm guidewire other information: - ifu was not followed.- the catheter was used like an angiographic catheter - notify date of event (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRAILBLAZER SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 4600 nathan lane; plymouth MN 55442
• MDR Report Key: 7361039
• Report Number: 2183870-2018-00172
• Device Sequence Number: 113140
• Product Code: DQY
• UDI-Device Identifier: 00821684073940
• UDI-Public: 00821684073940
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2020
• Device Catalogue Number: SC-035-090
• Device Lot Number: A486853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 04/06/2018; 05/25/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 05/02/2018; 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention