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

Model Number	SC-018-135
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
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 used a trailblazer device during patient treatment.The device was introduced in the patient with a guide.It is reported during the extraction the device became broken.The detached part did not remain in the patient and was found on the guide.No patient injury reported.
Additional Manufacturer Narrative
It was reported that in 2016, patient had a previous revascularization of the right limb.Reoccurrence of claudication continued.Under ultrasound, the right common femoral artery was used or antegrade direction.A 4fr introducer was placed.It was completed by an attempt to clear the sfa.The puncture of the common femoral was very difficult due to the presence of calcification build up and was difficult to cross.Passage was completed by a 0.35 guide on which a 4f catheter was mounted.The introducer was replaces by a 6f.Heparin was used through an iv.The angiography detected bulky plaque and calcification of the right sfa.All attempts to recanalize the right sfa was unsuccessful by antegrade approach, despite using many catheters, guides (0.35, 0.18, and 0.14).After an of hour of trying, physician performed the retrograde approach and incised the femoropopliteal at the level of the stent and retrograde recanalization of the sfa using a 0.18 guide and a micro snare (amplatz 2.5 lasso).Once the guide was outside the 6f antegrade introducer, a trailblazer catheter for crossing the antegrade occlusion was used on the 0.18 guide.The trailblazer was lowered to the retrograde puncture of the femoral.The recovery of the guide was difficult and it was finally able to be returned to the right direction.The new passage of the guide in the 0.18 catheter was impossible and physician had to cut the end of the catheter to be able to introduce the guide to the middle 1/3 of the femoral, progression of the guide was proving to be difficult and impossible despite many attempts.All material must be removed and an extremely damaged kinking of the trailblazer which could not withstand the calcified plaque observed.The removal of the material was accompanied by the displacement of the introducer 6f at the level of the common "femoral" which made physician stop the procedure and make manual compressions.It was reported that when physician retired the trailblazer, it was broken.After obtaining recanalization of the right sfa by retrograde approach, they did not conclude the intervention due to the defect of 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.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 microsnare was used to support procedure.A non-medtronic guidewire was used during procedure.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
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.

• Brand Name: TRAILBLAZER SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 11647273
• Report Number: 2183870-2021-00138
• Device Sequence Number: 14413847
• Product Code: DQY
• UDI-Device Identifier: 00763000104771
• UDI-Public: 00763000104771
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2021

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: 08/26/2023
• Device Model Number: SC-018-135
• Device Catalogue Number: SC-018-135
• Device Lot Number: B076166
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 07/12/2021; 09/22/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 07/02/2021; 07/28/2021; 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR