MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV BIO-MEDICUS LIFE SUPPORT TM; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	LS96218-019
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an obstructed cannula was identified with the bio-medicus life support catheter and introducer during use.The use of the device was unspecified.No patient complications have been reported as a result of this event.
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
Correction h6: eval code result (fdr/annex c) added.Correction h11: updated device evaluation summary: visual inspection shows the hemostasis cap was not returned.Additional visual inspection under magnification shows evidence of a blockage/fm inside the tip.A 0.038 inch guidewire would not fit in/through the tip.The introducer tip id was measured using a keyence scope.Introducer tip inner diameter (id) was measured to be 0.037 inches, the specification has the tip id to be 0.040 +0.002 / - 0.001 inches.Reason for the return was 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
Device evaluation summary: visual inspection shows the hemostasis cap was not returned.Additional visual inspection under magnification shows evidence of a blockage/fm inside the tip.A 0.038 inch guidewire would not fit in/through the tip.The introducer tip id was measured using a keyence scope.Introducer tip id was measured to be 0.037 inches, the specification m725749b001 has the tip id to be 0.040 +0.002 / - 0.001 inches.Reason for the return was confirmed.Correction b5: it was reported that an obstructed cannula was identified with the bio-medicus life support catheter and introducer during use.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.Additional info b5: medtronic received additional information that a blockage was identified within the device.Additional info h6: updated the annex c code additional info h6: updated the annex b code additional info d3: updated manufacturer name, and postal code additional info d9: device availability updated/ and device return date 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: BIO-MEDICUS LIFE SUPPORT TM
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• 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: 22455971
• Report Number: 9612164-2025-03369
• Device Sequence Number: 8118763
• Product Code: DWF
• UDI-Device Identifier: 00763000615437
• UDI-Public: (01)00763000615437(17)271202(10)230206676(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K240534
• 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
• Report Date (Section B): 09/24/2025

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: LS96218-019
• Device Catalogue Number: LS96218-019
• Device Lot Number: 230206676
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 09/24/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/06/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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