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

Catalog Number	SC-018-135
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/23/2018
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
It was reported that a trailblazer catheter broke and that a piece of catheter remained in the patient body.
Additional Manufacturer Narrative
The trailblazer unit was returned loaded inside a protective hoop.No ancillary devices were included.Visual inspection was performed.It was observed the distal end of the catheter was fractured.The working length of the catheter was approximately 138.5cm.The two distal marker band were not returned.The proximal marker band was located approximately 4.5cm from the distal end of the catheter.Approximately 0.5cm proximal the marker band the trailblazer was kinked.The trailblazer showed signs of the catheter material stretching distal the marker band.Analysis summary/results: the trailblazer was fractured and the distal portion was not returned for investigation.The distal portion likely included two of the three marker bands.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7585465
• Report Number: 2183870-2018-00324
• Device Sequence Number: 1590452
• Product Code: DQY
• UDI-Device Identifier: 00821684073919
• UDI-Public: 00821684073919
• 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,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 04/29/2018
• Device Catalogue Number: SC-018-135
• Device Lot Number: A252330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 06/22/2018; 08/08/2018
• Initial Report FDA Received Date: 06/10/2018
• Supplement Report FDA Received Date: 07/20/2018; 10/04/2018
• 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: Other
• Patient Age: 83 YR