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

Catalog Number	SC-035-135
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the catheter shaft reveal a kink.The kink is approximately 14.5cm proximal from the distal tip.Visual inspection under magnification of the kink location reveal a tear/fracture of the catheter shaft.This is evident during flushing of the catheter lumen.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a trailblazer device during treatment of a soft tissue lesion in the patient¿s distal aorta.Moderate calcification and severe tortuosity are reported.No stenosis reported.Ifu was followed.It is reported a kink occurred distal on catheter during initial advancement of the device.The catheter was not gripped at the distal tip.Minimal resistance was experienced during withdrawal, but removed without issue.A different catheter was used to complete the procedure.No injury reported.When the device was returned to the manufacturing facility for evaluation, it was noted that the shaft was damaged.

• Brand Name: TRAILBLAZER SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9171755
• Report Number: 2183870-2019-00492
• Device Sequence Number: 14036840
• Product Code: DQY
• UDI-Device Identifier: 00763000104818
• UDI-Public: 00763000104818
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: 04/28/2022
• Device Catalogue Number: SC-035-135
• Device Lot Number: A822279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 99