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

Model Number LA6JR35

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Material Deformation (2976)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 03/09/2024

Event Type  Injury  

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.

Event Description

An attempt was made to use one 6f launcher guide catheter during coronary intervention surgery.The patient was diagnosed with coronary heart disease.During the procedure the launcher guide catheter was smoothly sent the into the aorta through the right radial artery sheath, under the guidance of the guidewire, according to the usual operating procedures.It was reported that the patient complained of severe pain in the surgical limb.Digital subtraction angiography (dsa) fluoroscopy of the surgical limb revealed that the launcher was twisted and kinked in the right forearm.Several attempts to withdraw the launcher were unsuccessful.The right femoral artery route was re-selected to successfully complete the coronary stent implantation.After the coronary artery surgery, the patient was transferred to surgery to remove the launcher guide catheter.No further patient injury reported.

Manufacturer Narrative

Additional information: the launcher was being used in the right coronary artery (rca).There was total occlusion of the proximal segment of the rca.The left anterior descending (lad) artery had diffuse disease, with 80-90% stenosis.The guide catheter was inspected according to preoperative procedures with no issues noted.The device was prepped per the ifu before use with no issues noted.The device was not excessively torqued.Resistance was not noted during the insertion/delivery of the device.Excessive force was not used.The proximal section of the launcher was twisted and kinked.Resistance was noted during attempted removal of the device, but excessive force was not used.The patient has recovered and been discharged.Patient weight and history provided.Image analysis: three images were provided showing the launcher guide catheter in the vasculature.One of the images sent is duplicated.The images appear to show that the radial artery is tortuous midway up the right arm.The vessel in the body down to the ostium of the rca also appears to be somewhat tortuous.This suggests that the tortuosity may have impacted on the launcher becoming kinked and twisted.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
• Type of Device: 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: 18990052
• MDR Text Key: 338779057
• Report Number: 9612164-2024-01505
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00763000391935
• UDI-Public: 00763000391935
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LA6JR35
• Device Catalogue Number: LA6JR35
• Device Lot Number: 224379405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 72 KG