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

Catalog Number	SC-018-135
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a trailblazer with a 6f x 45 cm non-medtronic sheath and 0.018 non-medtronic guidewire during treatment of a fibrous cto (chronic total occlusion -100%) in the mid left superficial femoral artery (sfa).Slight tortuosity and moderate calcification were reported.Ifu was followed.It is reported the wire appeared to have perforated the trailblazer.From angiographic appearance, the wire prolapsed in the artery outside of the support catheter.The wire and trailblazer were both removed from the patient with no issues noted.The procedure was aborted.No injury reported.
Additional Manufacturer Narrative
Additional information: no intervention was required for removal of the device from the patient.There was no injury to the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: the trailblazer was returned.Visual inspection: the trailblazer was inspected and found a green 0.016" guidewire loaded.Approximately 164cm of the guidewire was exposed outside from the manifold of the trailblazer.It was observed the guidewire was loaded to the tip of the trailblazer.The three marker bands were identified on the trailblazer and were intact.Kinks to the trailblazer were identified within the location of the three marker bands at the distal end of the catheter.Dried blood was noted with the inner diameter of the catheter shaft.Functional testing: the gw was attempted to be removed; however it was stuck inside the lumen of the gw.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: 8141650
• Report Number: 2183870-2018-00572
• Device Sequence Number: 16616234
• Product Code: DQY
• UDI-Device Identifier: 00821684073919
• UDI-Public: 00821684073919
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K092299
• 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,Followup
• Report Date (Section B): 02/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2021
• Device Catalogue Number: SC-018-135
• Device Lot Number: A690178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 12/07/2018; 02/21/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 12/13/2018; 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR