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

Model Number	SC-035-090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/16/2020
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 intended to use a trailblazer support catheter with a 5mm sheath and 0.035 guidewire during treatment of a 200mm calcified cto (chronic total occlusion-100%) in the patient¿s distal left superficial femoral artery (sfa) of diameter 6mm.Severe vessel calcification and tortuosity are reported.Ifu was followed.Vessel pre-dilation was not performed.It is reported that during removal of the catheter, the proximal portion of the catheter broke off in the very calcified subintimal vessel.The procedure was aborted, and the detached portion was left in the patient¿s subintimal portion of the sfa.No patient injury reported.
Additional Manufacturer Narrative
Cine analysis: the customer provided a cine image where the trailblazer is visible within the vessel.Two of the three marker bands were visible on the cine.No fracture face of the trailblazer could be identified.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the detached portion of the catheter was attempted to be snared without success.No further intervention was carried out for the detached portion.No additional treatment was given to the patient.There is no plan to remove the detached portion of the device and the physician reported that a femoral popliteal bypass will be performed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 10552719
• Report Number: 2183870-2020-00300
• Device Sequence Number: 2705674
• Product Code: DQY
• UDI-Device Identifier: 00763000104801
• UDI-Public: 00763000104801
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/29/2020

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: 04/22/2023
• Device Model Number: SC-035-090
• Device Catalogue Number: SC-035-090
• Device Lot Number: B013162
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/18/2020; 10/26/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 09/22/2020; 10/29/2020
• 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: 87 YR