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

Model Number SC-035-135

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.(b)(4).

Event Description

The wire went thru the wall of the trailblazer catheter.The wire was a stiff wire and the issue occurred while the wire and catheter were in the patient, trying to go up and over.The physician pulled another trailblazer to finish the case.No injury reported.Evaluation of the returned device was performed on (b)(6), 2015.The wire used during the procedure was not returned with the trailblazer device.The trailblazer was removed from the protective hoop and could not find any damages or anomalies on the device.The distal end was clamped closed using a hemostat clamp.A 10ml syringe filled with water was attached and the plunger was pressed.Water was leaking from the catheter near the proximal marker band.A 0.014" gw from the lab was inserted and was unable to penetrate the hole observed during loading.The hole appeared using a microscope to show a longitudinal slice approximately 11cm from the distal tip of the trailblazer.

• 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 n; plymouth MN 55442
• Manufacturer Contact: mary haufek ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5323229
• MDR Text Key: 35002640
• Report Number: 2183870-2015-07621
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2017
• Device Model Number: SC-035-135
• Device Catalogue Number: SC-035-135
• Device Lot Number: A072259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1