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

Catalog Number	ASC-018-135
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the angled trailblazer support catheter was returned for evaluation.No ancillary devices, cine, images or procedure notes were returned for evaluation.When the device was removed from the packaging it was observed catheter was detached proximal from its hub underneath the strain relief.Visual inspection of the detached location of the catheter shows a twist.The distal section of the catheter was intact.All marker bands were accounted for.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using an angled trailblazer device as part of a procedure.It was reported the catheter broke in the sheath when trying to advance, prior to insertion into the patient.A new trailblazer was used to complete the procedure.There was no patient injury reported.When the device was received for evaluation, it was noted the device was damaged.

• Brand Name: TRAILBLAZER ANGLED
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9409470
• Report Number: 2183870-2019-00555
• Device Sequence Number: 11504774
• Product Code: DQY
• UDI-Device Identifier: 00763000004842
• UDI-Public: 00763000004842
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/04/2019

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: 06/25/2021
• Device Catalogue Number: ASC-018-135
• Device Lot Number: A666505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1