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

Catalog Number SC-014-150

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the trailblazer catheter was received for evaluation.No procedural reports or cine images from the procedure were received.The catheter was received with a 0.014¿ guidewire within its guidewire lumen.Push and pull forces were applied to the guidewire proximal and distal to the trailblazer: no advancement in either directions.The unknown 0.014¿ guidewire was approximately 3 meters in length.The trailblazer was approximately 146 cm distal of the proximal end of the 0.014¿ guidewire.A twist was felt within the trailblazer approximately 136.3 cm to 138 cm distal of the trailblazer strain relief distal tip.A second twist was located approximately 140 cm to 143 cm distal of the trailblazer strain relief distal tip.All components of the trailblazer are accounted for.The pouch label of the device was examined, the use before date is 2016-07-15.The event date is (b)(6) 2016.

Event Description

Physician attempted use a trailblazer catheter in the treatment of a patient at the left distal pedal artery.Target lesion had little tortuosity and little calcification.Device was advanced over bifurcation with no resistance noted.Guidewire was hydrated at prep.Severe resistance was experienced during initial advancement of the guidewire.It is reported that guidewire lock-up occurred.Both devices were removed in tandem.Procedure was completed using a second wire and catheter.No patient injury reported.No additional treatment received.During complaint assessment it was noted trailblazer was used past its expiry date.Patient has not received any further treatment.

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: 6056638
• MDR Text Key: 58357915
• Report Number: 2183870-2016-00649
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2016
• Device Catalogue Number: SC-014-150
• Device Lot Number: 9927107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• 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