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 Thrombosis (2100); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

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 support catheters (both angled and not angled).Survey results received for a cardiothoracic surgeon practicing in italy who within the last 12 months used a trailblazer not angled catheter in 250 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.Survey results received for a cardiothoracic surgeon practicing in italy who within the last 12 months used a trailblazer angled catheter in 150 procedures, and a trailblazer not angled catheter in 250 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.The following adverse events/complications were reported during use of the trailblazer angled support catheter: access site complications (15 occurrences, none of which were related to the device itself), local or systemic infection including sepsis (8 occurrences, none of which were related to the device itself), perforation and vessel rupture (6 occurrences, 2 of which were related to the device itself), and surgical intervention (5 occurrences, none of which were related to the device itself).For each of the complications reported, all were described as being not at all concerning, with the exception of the perforation and vessel rupture events which were described as somewhat concerning.For the perforation and vessel rupture events, the devices were used in hard-to-reach complex anatomies and the operator was aware that this was a potential complication as described in the ifu.The following adverse events/complications were reported during use of the trailblazer not angled support catheter: arterial dissection (11 occurrences, 2 which were related to the device itself), arterial spasm (20 occurrences, none of which were related to the device itself), arterial thrombosis (3 occurrences, none of which were related to the device itself), perforation and vessel rupture (5 occurrences, none of which were related to the device itself), and surgical intervention (12 occurrences, none of which were related to the device itself).For each of the complications reported, the arterial dissection (expected complication due to chronic occlusions) and arterial spasm events were reported to be not at all concerning; the perforation and vessel rupture events, and surgical intervention events were reported as being somewhat concerning; and the arterial thrombosis event (acute limb ischemia due to distal embolization) was reported as being very 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: 8969195
• MDR Text Key: 156878063
• Report Number: 2183870-2019-00434
• 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: Physician
• 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?: Yes
• 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