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	04/01/2019
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
The physician was using a trailblazer to treat a severely calcified lesion in the mid left common iliac artery.The artery had little tortuosity.The ifu was followed.It was reported that the tip of the device broke off and had to be snared.The procedure was aborted.
Additional Manufacturer Narrative
Additional information: a 5fr non-medtronic sheath was used.No resistance was encountered during advancement.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation visual inspection of the catheter revealed dried biological material occluded the entire length.All marker bands were accounted for on the catheter visual inspection of the catheter distal tip reveal no abnormalities or deformity.A kink was observed on the catheter shaft approximately 18mm proximal from the distal tip.The catheter total working length was measure to 135mm.A known good sc-035-135 catheter from analysis lab was measured in comparison with the returned trailblazer catheter to verify total length , marker placement and tip abnormalities: both devices radiopaque markers were observed in their respective locations and are 5cm apart per the product requirements indication of 5cm.Both devices were total lengths measured to 135cm.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: 8491516
• Report Number: 2183870-2019-00165
• Device Sequence Number: 1471252
• Product Code: DQY
• UDI-Device Identifier: 00821684073957
• UDI-Public: 00821684073957
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/28/2019

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: 01/10/2022
• Device Catalogue Number: SC-035-135
• Device Lot Number: A765176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/08/2019; 06/24/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/03/2019; 06/28/2019
• 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