MAUDE Adverse Event Report: MEDTRONIC INC LAUNCHER 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	LA6EBU35
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
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
During a procedure an attempt was made to use one 6f launcher guide catheter to treat a lesion. there was no damage noted to the packaging. the device was removed from the packaging per ifu with no issues noted.The device was inspected with no issues.The device was prepped per ifu with no issues noted.Resistance was not encountered when advancing the device.Excessive force was not used during insertion or delivery. it was reported that the tip of the catheter was noted to be broken after the procedure while removing the device.The patient is alive with no injury.
Additional Manufacturer Narrative
Additional information: the lesion was pre-dilated.Resistance was noted during withdrawal of the device.Excessive force was not used.The device was not kinked and re-straightened during use.The tip was partially detached and was successfully removed from the patient by slowly and patiently withdrawing it.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: device lot details updated device evaluation summary: one 6 fr launcher guide catheter was received for analysis.The device returned with a complete detachment of the tip.The tip did not return for analysis.The material was jagged and uneven on the detachment site.Deformation was noted on the device at the point of detachment, with the inner braiding exposed and protruding outwards.The outer sleeve material was discolored at the detachment site.Deformation was noted on the primary curve of the device with tears evident on the outer shaft material, exposing the inner braiding.There appeared to be hairline cracks on the surface of the outer shaft material.A kink was noted approx.90cm distal to the strain relief.No other damage was noted to the remainder of the device.Correction: annex g codes updated 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.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13926323
• Report Number: 1220452-2022-00027
• Device Sequence Number: 17724210
• Product Code: DQY
• UDI-Device Identifier: 00763000389451
• UDI-Public: 00763000389451
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K132673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2022

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: 05/24/2023
• Device Model Number: LA6EBU35
• Device Catalogue Number: LA6EBU35
• Device Lot Number: 222299531
• 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: 03/16/2022
• Supplement Date Received by Manufacturer: 04/12/2022; 07/12/2022; 10/04/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/25/2022; 07/26/2022; 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male