MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV BIO-MEDICUS LIFE SUPPORT TM; CATHETER, PERCUTANEOUS

Model Number	LS96360-025
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during the insertion of the bio-medicus life support catheter and introducer, after the product was placed in the intended position, the introducer could not be withdrawn, which was unusual for this product and not previously experienced by the hospital.The surgical procedure was performed following the usual protocol.No pre-use testing was performed due to the emergency of the case.The device was replaced to complete the procedure.The alternative model functioned normally without any complications.It was unknown if there was any complications as a result of the event.
Additional Manufacturer Narrative
Medtronic received additional information that the customer required approximately 15 minutes longer than usual to initiate cpb (car diopulmonary bypass), during which the patient experienced a pressure drop.The patient needed to be placed on cpb as soon as possible.After the new femoral replacement, the patient became stable and they started the procedure.After the procedure, the patient was better and already discharged from the hospital.No damage on the cannula had been observed.Device evaluation summary: visual inspection shows no outward signs of any damage.Note: the customer has provided a video showing evidence of the introducer not being able to be removed.The introducer was inserted and removed from the cannula several times with no issues observed.The introducer od was measured using a keyence scope and the cannula id was measured using a pin gage.Introducer od was measured to be 0.281 inches, the specification has the od to be 0.281 +0.005 / -0.003 inches cannula id was measured to be 0.275 inches, the specification has the id to be 0.267 to 0.276 inches reason for return was undetermined.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: BIO-MEDICUS LIFE SUPPORT TM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22563742
• Report Number: 9617601-2025-00670
• Device Sequence Number: 14451631
• Product Code: DQY
• UDI-Device Identifier: 00763000615581
• UDI-Public: (01)00763000615581(17)271127(10)230162807(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K201057
• 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
• Report Date (Section B): 08/26/2025

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: LS96360-025
• Device Catalogue Number: LS96360-025
• Device Lot Number: 230162807
• 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: 07/20/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/26/2025
• Date Device Manufactured: 11/27/2024
• 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
• Patient Sex: Unknown
• Patient Weight: 47 KG