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

Catalog Number SC-014-135

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Perforation (2001); Sepsis (2067); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the trailblazer not angled support catheter.Survey results received for a vascular surgeon practicing in italy who within the last 12 months used a trailblazer (not angled) catheter in 36 procedures to guide and support a guidewire during access of the vasculature, to allow for wire exchanges, and/or to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.During use of the trailblazer device the following adverse events/complications were reported: intimal disruption (4 occurrences, 1 of which is reported as being related to the device itself), local or systemic infection including sepsis (4 occurrences, none of which are reported as being related to the device itself), perforation and vessel rupture (1 occurrence, which is not reported as being related to the device itself), and surgical intervention (1 occurrence, which is not reported as being related to the device itself).For each of the complications reported, intimal disruption (described as a small intimal laceration treated with medical therapy and watchful waiting) and local or systemic infection including sepsis were reported to be not at all concerning; the perforation and vessel rupture and surgical intervention are reported to have been somewhat concerning.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRAILBLAZER SUPPORT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8968860
• MDR Text Key: 156723803
• Report Number: 2183870-2019-00432
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K092299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SC-014-135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention