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

Catalog Number	SC-018-090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a trailblazer catheter with a non-medtronic sheath and a non-medtronic 0.018¿ guidewire for the treatment of a 20mm severely calcified lesion in proximal location of the left anterior tibial artery of diameter 3mm.Vessel reported as being moderately tortuous.Lesion exhibited cto (chronic total occlusion-100%).Ifu was followed.The vessel was not pre-dilated.It was reported the lesion was crossed with the guidewire but physician was unsuccessful in crossing with.018 balloon.Physician then attempted to cross with an.018 trailblazer.When pushing the trailblazer back, it was reported to have broken after the first proximal marker.The catheter did not break into multiple segments.The catheter segment was not stuck on the guidewire.The detached portion was left in the vessel and the procedure was stopped.The detached portion of the catheter was then explanted surgically.Patient status unknown.
Additional Manufacturer Narrative
Device evaluation summary: the trailblazer support catheter received was approximately 88.7cm in length and included only one radiopaque marker band.The support catheter exhibited signs of tensile stretching and necking down.A 0.018¿ guidewire was loaded through the proximal hub luer lock and would advance only 88cm of the returned trailblazer¿s length.Approximately 30mm of support catheter and two radiopaque marker bands were not returned.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: 7053446
• Report Number: 2183870-2017-00522
• Device Sequence Number: 16369516
• Product Code: DQY
• UDI-Device Identifier: 00821684073902
• UDI-Public: 00821684073902
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/18/2017

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: 03/20/2020
• Device Catalogue Number: SC-018-090
• Device Lot Number: A432630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 12/18/2017
• 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