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

Catalog Number	SC-035-090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a trailblazer to treat a moderately calcified lesion with 75% stenosis in the proximal right iliac artery.A non-medtronic 7fr sheath and a non-medtronic 0.35x260 guidewire were used.Ifu was followed pre, during and post procedure.The catheter was being removed over the guidewire when resistance was felt as the device came over the aortic bifurcation.The physician continued to pull and the catheter broke in two.Catheter segments got stuck on the guidewire and were retrieved with a non-medtronic snare system.All diagnostic images required had already been obtained so the procedure was completed.All wires and sheaths were removed.No patient injury was reported.
Additional Manufacturer Narrative
Medwatch report received.Report number: mw5080404.Evalaution summary: the trailblazer unit was returned for evaluation in two segments with a non-medtronic snare device.No other ancillary devices were included.The trailblazer and non-medtronic snare device were inspected.The snare device indicated 6f on the purple hub of the unit.The snare was exposed outside the distal end of the snare catheter showing multiple hoops.No portion of the trailblazer was observed with the hoops of the snare.It was discovered the trailblazer was fractured into two segments.The distal portion of the trailblazer showed 3 marker bands.Dried blood was observed within the lumen of the catheter.The distal marker band showed no damages to marker band or catheter shaft.The medial marker band was identified approximately 5cm from the distal marker band.Between the medial and proximal marker band, the catheter shaft was stretched and flattened.The proximal marker band was approximately 7cm from the medial marker band.The proximal marker band showed a flat crease to the catheter shaft at the distal face of the proximal marker band.Stretching/flattening of the catheter shaft proximal to the proximal marker band was noted.The total length of the distal segment was approximately 21.5cm cm.The fracture face of the distal segment showed a radial fracture with the catheter showing signs of stress from excessive tensile forces.The proximal segment of the trailblazer was approximately 73.5cm long (working length).The fracture face was radial and showed signs of stress excessive tensile forces.The grand total working length for both segments was approximately 95cm.The product labeling associated to the trailblazer lot a590503 indicates a working length of 90 cm and 5cm between marker bands.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: 8028178
• Report Number: 2183870-2018-00485
• Device Sequence Number: 16441037
• Product Code: DQY
• UDI-Device Identifier: 00821684073940
• UDI-Public: 00821684073940
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: SC-035-090
• Device Lot Number: A590503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 100