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

Catalog Number	SC-035-135
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician employed the use of a trailblazer support catheter during treatment of a severely calcified lesion in the mid common iliac artery.Vessel described as being moderately tortuous.Lesion exhibited 70% stenosis.Ifu was followed.Vessel was not pre-dilated.It was reported that the trailblazer catheter tip (10cm) broke off of a non-medtronic 260cm guidewire.Tip was recovered with a non-medtronic snare device.All segments were retrieved, none stuck on guidewire.A new trailblazer catheter was opened to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the trailblazer support catheter was returned in 2 two segments in 2 separate bags.No ancillary devices, cine images or procedure notes were returned for evaluation.The proximal segment was measured from the distal end to the strain relief was approximately 126cm long.Only one radiopaque marker was observed.The yellow strain relief indicates that the device is 0.035in x 135cm trailblazer support catheter.The distal segment was inspected and measured to be approximately 9cm in length.No damage was noted to the distal tip.A kink was observed on the distal segment of the catheter.The distal segment showed traces of blood within the lumen.Two radiopaque markers were observed on the distal segment of the catheter.When the entire length of the catheter ws measured, it was observed that the catheter separated approximately 10cmm proximal to the distal tip.The total length of both segments was approximately 135cm and according to the product labelling the working length is 135cm.Visual inspection under magnification revealed the separation of the catheter may have resulted from torsion and tension stretching of the catheter.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: 7124803
• Report Number: 2183870-2017-00590
• Device Sequence Number: 19129210
• Product Code: DQY
• UDI-Device Identifier: 00821684073957
• UDI-Public: 00821684073957
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K092299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 07/26/2020
• Device Catalogue Number: SC-035-135
• Device Lot Number: A498519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/18/2018
• 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
• Patient Age: 51 YR