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

Model Number	LS96360-023
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic received additional information that the catheter was positioned in the right femoral vein and the tip of the cannula was placed in the svc/ra (superior vena cava/right atrium) junction when the issue occurred.The cannula was opened from box before the cannulation start.Insertion started approximately 5-10 minutes after opening.Correction d2: product code, common device name.Correction d3: mfr name, postal code.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
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 use of a bio-medicus life support cannula, while the cannula was inserted into the femoral vein of the patient the customer could not remove the dilator from the sheath.The device was replaced.No patient complications have been reported for this event.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows no outward signs of any damage.The introducer od was measured using a keyence scope and the cannula tip id was measured using a plug gage.Introducer od was measured to be 0.257 inches, the specification has the od to be 0.256 +0.005 / - 0.003 inches cannula tip id was measured to be 0.250 inches, the specification m969351a002 has the id to be 0.243 to 0.252 inches.The introducer was inserted and removed several times with no issues noted.Reason for the return was not confirmed.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 b5.Medtronic received additional information that the device was used for redo mvr.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 b5.Medtronic received additional information that the device was not used in extracorporeal membrane oxygenation (ecmo), the customer stated it was used in re-do mvr meaning "re-do operation mitral valve repair." 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 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22712517
• Report Number: 9612164-2025-03820
• Device Sequence Number: 9393475
• Product Code: DQY
• UDI-Device Identifier: 00763000615574
• UDI-Public: (01)00763000615574(17)271007(10)229815578(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/27/2025

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: LS96360-023
• Device Catalogue Number: LS96360-023
• Device Lot Number: 229815578
• 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: 08/02/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 09/04/2025; 11/12/2025; 10/26/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/02/2025; 10/01/2025; 11/26/2025; 11/27/2025
• Date Device Manufactured: 10/07/2024
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 48 KG