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

Catalog Number	SC-035-135
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
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
Physician used a trailblazer support catheter with a 6fr sheath and non-medtronic (glidewire) wire during treatment of a 30mm cto (chronic total occlusion-100%) in the patients left proximal superficial femoral artery (sfa).Artery diameter is reported as 7mm.No tortuousity and severe calcification are reported.Ifu was followed and the device was prepped without issue.It is reported that a kink was observed on the distal catheter during second advancement of the device.The catheter was not gripped at the distal tip.When the trailblazer was removed from the patient a piece was observed to be remaining in the patients common femoral artery beside and distal to the sheath.A snare was used to remove the detached portion.No patient injury reported.
Additional Manufacturer Narrative
Product analysis the trailblazer was inspected and found the catheter fractured apart in two segments with dried blood within the lumen.The proximal segment of the trailblazer showed the distal tip/fracture face as being ductile and showed evidence of stretching.The end of the catheter was flattened.The proximal marker band was located approximately 15cm from the fracture face of the catheter.Under microscope, the proximal marker band was viewed, and the catheter shaft showed bending/buckling of the catheter shaft at the distal and proximal edge of the marker band.The proximal segment was approximately 135cm in working length.The distal segment of the trailblazer which fractured off was approximately 5cm long.The medial and distal marker bands were observed.The medial marker band showed the proximal edge crushed/flattened.The distal maker band found no damages but showed a bend proximal to the marker band at an approximate 90-degree angle.Image review a cine image was provided and a photo of the trailblazer.The cine image provided likely shows the distal end of the trailblazer showing the distal and medial marker bands loaded over a guidewire.If could not be determined from the cine image if the catheter exhibited damaged.The provided photo shows the trailblazer with blood observed throughout the lumen.The photo showed the distal end of the proximal segment of the fractured catheter.The end of the catheter visible in the photo shows the tip bent upward.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: some resistance was encountered when removing the device excessive force was not required.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 8408078
• Report Number: 2183870-2019-00122
• Device Sequence Number: 389194
• Product Code: DQY
• UDI-Device Identifier: 00821684073957
• UDI-Public: 00821684073957
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 06/14/2019

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: 02/04/2022
• Device Catalogue Number: SC-035-135
• Device Lot Number: A777694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/11/2019; 06/04/2019; 06/04/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 03/21/2019; 06/14/2019; 06/14/2019
• 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: 68 YR
• Patient Weight: 73