MAUDE Adverse Event Report: MEDTRONIC, INC. LAUNCHER; CATHETER, PERCUTANEOUS

Model Number	LA7JL40
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: a guide catheter kinked in the radial artery when clocking for the procedure.This ultimately required a vascular doctor to come and do a cut-down and ligation of the radial artery.This was during a pci [percutaneous coronary intervention] attempt for an ostial left anterior descending lesion, on a patient with an intra-aortic balloon pump already in place right femoral.We had not yet gotten very far in the attempt; no wire was advanced into the coronary artery yet.I think this event happened because of radial access being more torturous, guide catheters being thinner walled than other catheters, possible equipment failure (guide catheter).This is somewhat unavoidable, although it could be mitigated by preferentially using femoral access in cases like this, although that would increase the risk of life-threatening hematoma or retroperitoneal bleed, so it may not be beneficial to prefer femoral access.From operative report: aborted pci attempt of proximal lad [left anterior descending] after guide catheter became entrapped in the right forearm due to catheter manipulation.Attempts to straighten out the catheter failed despite use of multiple wires.We also tried advancing a 7 and 8 french dilator over the guide catheter without success.Therefore, vascular surgery was requested to assist with retrieval.Radial cut-down performed and removed the catheter in two pieces.The radial artery was sutured.Arterial doppler confirmed robust ulnar arterial pulsation.No further intervention was performed.Lad pci completed following day.

• Brand Name: LAUNCHER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 22505857
• Report Number: 22505857
• Device Sequence Number: 15616288
• Product Code: DQY
• UDI-Device Identifier: 00613994832030
• UDI-Public: (01)00613994832030
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2025
• Report Date (Section F): 06/24/2025

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 Model Number: LA7JL40
• Device Catalogue Number: LA7JL40
• Device Lot Number: 0012214535
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Date Report Sent to FDA: 06/24/2025