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

Model Number	LA6JR40
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attempt was made to use a launcher guide catheter to treat a severely tortuous lesion in the right coronary artery (rca).There was no damage noted to the device packaging.There were no issues noted when removing the device from the protective hoop.The device was inspected with no issues noted.Negative prep was performed with no issues.Resistance was encountered when advancing the device.Excessive force was used during delivery.The device was excessively torqued.It was reported that the device was kinked while in the patient and when trying to advance it to the right coronary artery a detachment occurred.The physician was torqueing the device when it broke off at the right femoral artery above the sheath.An attempt was made to snare the detached part but it could not be retrieved.The patient underwent a surgery to get a cut down to remove the detached portion.The patient is alive and no further injury was reported.
Additional Manufacturer Narrative
Additional information: it was reported that when advancing the guide catheter loss of pressure/arterial waveform was noted.It was stated that the event occurred in the iliofemoral system and extending into the descending thoracic aorta.Excessive force was not used during the withdrawal of the device.Relevant history added to b7 patient age, weight provided correction: annex e code updated pma / 510(k) # updated manufacturer address 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
Additional information: the detachment occurred on the shaft, approximately 14-16 inches from the hub.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: 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12532436
• Report Number: 9612164-2021-03694
• Device Sequence Number: 11126249
• Product Code: DQY
• UDI-Device Identifier: 00763000344610
• UDI-Public: 00763000344610
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021

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 Expiration Date: 02/11/2023
• Device Model Number: LA6JR40
• Device Catalogue Number: LA6JR40
• Device Lot Number: 221686881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 12/08/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/27/2021; 12/16/2021
• Date Device Manufactured: 02/11/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 79 KG