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

Catalog Number	SC-035-090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician intended to use a trailblazer support catheter for an endovascular aneurysm repair (evar) procedure of the left internal iliac artery.Device ifu was followed.The physician was trying to access to the internal iliac artery using a non-medtronic 0.035" guidewire but the anatomy was tortuous so they inserted the trailblazer to gain extra support.However, the catheter snapped as it was being advanced.It is believed it snapped into two segments.The catheter segments were reported to be stuck on the guidewire.All segments were retrieved as the physician managed to pull the wire and the catheter out.The physician managed to gain access following this and continue the procedure.No patient injury reported.
Additional Manufacturer Narrative
Evaluation summary: approximately 80.5cm of the 90cm working length of the support catheter was received.Two kinks in the catheter were noted approximately 72.3cm and 73.5cm distal of the distal tip of the printed strain relief.Of the three radiopaque marker bands on the catheter only the proximal radiopaque marker band was returned.Approximately 9.5cm working length of the support catheter that includes the middle and distal radiopaque marker bands were not return.The separation face just distal of the proximal radiopaque marker band exhibits torsional twisting and stretching.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): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6746687
• Report Number: 2183870-2017-00317
• Device Sequence Number: 19232952
• Product Code: DQY
• UDI-Device Identifier: 00821684073940
• UDI-Public: 00821684073940
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2020
• Device Catalogue Number: SC-035-090
• Device Lot Number: A416829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1