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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician attempted to use a trailblazer support catheter during procedure to treat a plaque lesion in the patients right proximal s uperficial femoral artery (sfa).There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without iss ue.Embolic protection was not used.The vessel was not pre or post dilated.The device was not passed through a previously deployed stent.No resistance was not encountered when advancing the device.It was reported the tip of trailblazer support catheter detached in patients vessel.A snare was used to remove detached component.A replacement non-medtronic device was used to complete procedure.No patient injury reported.
Additional Manufacturer Narrative
Failure to osseointegrate is a well-known and inherent risk of dental implants and is documented in the literature across implant systems1, 2 (see e.G., keller, 1995; bornstein, 2008,).Paltop dental solutions inc.Provides ifu with all implants.Failure to osseointegrate and loss of osseointegration (implant mobility) is identified as an adverse reaction and identified in the list of warnings in all end-osseous dental implant labeling.The specific cause for a particular complaint is often not readily identified as there are various factors that contribute to the risk of implant failure.These include systemic medical conditions (uncontrolled diabetes mellitus, aids, osteoporosis), poor bone quality and quantity of bone in which the implant is implanted, medications (corticosteroids, bisphosphonates), harmful habits to healing (smoking), secondary infection and/or surgical trauma, unexperienced clinician, improper surgical technique, or mobility of the implant leads to its removal or replacement, hence dental implant failure.In addition, a rate of implant failure that does not affect the products'' risk assessment does not require investigation as it is a well-known failure mode that has been adequately studied in the past.
Additional Manufacturer Narrative
Product analysis: the device returned in two parts.Size on strain relief is 0.035¿ x 135cm.A stretch was observed on the catheter.An inhouse 0.035 wire was loaded in through the hub and could not exit the tip of the device due to the stretching and damage observed on the device.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: TRAILBLAZER SUPPORT CATHETER
• Common Device Name: 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19132411
• Report Number: 2183870-2024-00128
• Device Sequence Number: 19997975
• Product Code: DQY
• UDI-Device Identifier: 00763000762810
• UDI-Public: 00763000762810
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K092299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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 Catalogue Number: SC-035-135
• Device Lot Number: B690824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Female