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

Model Number	LA6JR35
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a coronary angiogram procedure an attempt was made to use one 6f launcher guide catheter in an attempt to engage the right coronary artery (rca).It was reported that the guide catheter and wire slipped back from the aorta to the patient's right forearm.On xray the guide catheter could be seen to have a knot in it and was stuck in the patient, causing pain with any pushing and pulling.Interventional radiology (ir) service was contacted to come and take a look at the retained knotted catheter.An ultrasound was carried out on the affected vessel and below the catheter knot showed good arterial blood flow proximal to the knot and could see that the knot was tightly wedged into place in the artery.Surgery was deemed necessary and femoral access of the right femoral artery was obtained to complete an angiogram of the right arm for anatomical imaging.The patient was then taken off the table and brought to the operating room (or) for possible cut down and removal of the retained catheter.Graft harvest technique from the leg was attempted, which did not remain patent but was ensured that adequate perfusion of the distal extremity was obtained.The patient has continued to have ongoing arm pain.The patient is alive with no further injury.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: the device was inspected prior to use with no issues noted.The device was prepped per ifu.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: annex d code added.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19358703
• Report Number: 9612164-2024-02426
• Device Sequence Number: 15056682
• Product Code: DQY
• UDI-Device Identifier: 00763000705534
• UDI-Public: 00763000705534
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2024

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: 05/31/2025
• Device Model Number: LA6JR35
• Device Catalogue Number: LA6JR35
• Device Lot Number: 226696303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 06/17/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/06/2024; 06/18/2024
• Date Device Manufactured: 05/31/2023
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White