MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 7F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	LA7JL35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Obstruction/Occlusion (2422); Vascular Dissection (3160); Thrombosis/Thrombus (4440)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
An attempt was made to use two launcher guide catheters to treat a severely tortuous, moderately calcified lesion with 100% cto (chronic total occlusion) in the mid left anterior descending (lad) artery and circumflex (cx) artery.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 lesion was also treated with three non-medtronic guidewires, a non-medtronic balloon and a non-medtronic cutting balloon.A non-medtronic micro catheter was also used during the procedure.It was reported that a vessel occlusion occurred due to a device component.It was also reported that thrombosis/clots occurred after the procedure in the lad.The physician suggested the adverse event is device related, as clot has occurred after the use of the launcher during the procedure.The patient was on dapt at the time of the event.The event was treated with anti thrombolytic agents.No further patient injury as reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received: the 100% cto (chronic total occlusion) was caused by a fibrotic lesion.It was reported that dissection and perforation occurred during the procedure in the lad.It t was suggested the vessel occlusion to be caused by thrombosis/clots noted during ecg and coronary angiogram, during the procedure.The physician suggested the adverse events are due to a device component.Correction: both devices were inspected with no issues noted.Resistance was encountered for both devices.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: fdc code added correction: fdr code added.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
Product analysis: the lot number matches details in the complaint file.One 7 fr launcher guide catheter was received for analysis.Guide catheter was flushed before decontamination with no evidence of thrombus or foreign material inside the device.A 0.035 inch guidewire was loaded through the lumen with no resistance noted.No damage was noted to the distal tip.No other damage was noted to the remainder of the device.Correction: negative prep was not performed on the launcher devices.Instead the devices were prepped per ifu with no issues.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 7F 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: 13151536
• Report Number: 1220452-2022-00001
• Device Sequence Number: 4079018
• Product Code: DQY
• UDI-Device Identifier: 00613994832092
• UDI-Public: 00613994832092
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K022764
• 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): 03/29/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: LA7JL35
• Device Catalogue Number: LA7JL35
• Device Lot Number: 0010588356
• 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: 12/06/2021
• Supplement Date Received by Manufacturer: 01/10/2022; 03/14/2022; 03/28/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/17/2022; 03/23/2022; 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male