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

Model Number	ASC-018-150
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
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 an angled trailblazer support catheter during left leg angioplasty of the superficial femoral artery (sfa).It is reported the ostial sfa was engaged using the angled trailblazer device and a non-medtronic wire.The physician upgraded to a 0.035 stiff angled wire and non-medtronic support catheter.It is reported the physician was unable to pass the catheter beyond the distal sfa and the wire and catheter were changed for a non-medtronic 0.018 wire and traiblazer to make a second attempt.It is reported the physician still had trouble and decided to perform angioplasty of the entire sfa.It is reported the wire appeared to be in the lumen at the popliteal artery.The physician advanced the trailblazer but difficulty was experienced and during the advancement attempt the device kinked.The physician was unable to remove the wire and had to remove the entire system, it is reported during the manipulation the hub broke off the device.It is reported the wires would not slide through the catheter and felt sticky.No patient injury reported.
Additional Manufacturer Narrative
Additional information: physician reported that the inside of the catheter felt sticky when attempting to pass the wire, nothing was noted to the outside of the catheter.Only one trailblazer was used during this procedure.The patient was safely removed from the patient.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: ifu was followed.It is unknown when the hub detached off the device.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.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
Device evaluation the guidewire received with the trailblazer angled catheter was a 0.018¿ compatible guidewire and exhibited kinks along its length.The hub from the trailblazer angled support catheter was not returned.Per the initial reported event description, the physician broke the hub on the catheter during the procedure.The guidewire and the trailblazer angled support catheter exhibited a tight kink that locked the two devices together.The three distal radiopaque marker bands remained attached to the catheter.Approximately 153cm of the catheter were returned.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.

• Brand Name: TRAILBLAZER ANGLED
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 11009973
• Report Number: 2183870-2020-00438
• Device Sequence Number: 4396434
• Product Code: DQY
• UDI-Device Identifier: 00763000104696
• UDI-Public: 00763000104696
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/18/2021

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: 03/17/2023
• Device Model Number: ASC-018-150
• Device Catalogue Number: ASC-018-150
• Device Lot Number: A994258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 01/08/2021; 03/16/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 12/18/2020; 01/11/2021; 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 85