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

Catalog Number	SC-018-150
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fda report number: (mw5083345).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A physician was using a trailblazer support catheter in a procedure.It was reported that a patient had distal aortography with runoff, left lower extremity angiography, angioplasty of the left anterior tibial artery.This procedure was complex and required multi-site access: right common femoral artery in addition to ultrasound-guided access to the left distal anterior tibial artery.The right femoral artery was accessed utilizing the micropuncture technique.A 5-french non-medtronic (omniflush) catheter and a 6-french cook sheath were used.The sheath was placed in the superficial femoral artery.Angiography performed.The 0.035 trailblazer support catheter became stuck on the non-medtronic 0.035 (halberd) guidewire.The catheter guidewire was externalized through the distal anterior tibial access site.In pulling on the catheter, the distal tip of the support catheter was broken off.The support catheter was subsequently dislodged from the guidewire and removed from the body without any other difficulty.The procedure continued without any adverse effect to the patient.
Additional Manufacturer Narrative
Updated initial reports name additional information: the 0.035 trailblazer support catheter was used in the mid to distal anterior tibial.Pedal access was achieved in order to try and snare the wire but this was not successful.The physician then decided to abort the case and removed the trailblazer.This was when the distal part was noticed to have detached from the trailblazer.It was removed from the patient on the glidewire.No product or device remained in the patient.The patient is reported to be doing fine.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: 8393876
• Report Number: 2183870-2019-00116
• Device Sequence Number: 11527372
• Product Code: DQY
• UDI-Device Identifier: 00821684073926
• UDI-Public: 00821684073926
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061188
• 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): 04/30/2019

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: 05/13/2021
• Device Catalogue Number: SC-018-150
• Device Lot Number: A644691
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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
• Patient Age: 86 YR