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	LS96550-017
Medical Device Problem Codes	Crack (1135); Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
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 after a patient was placed on ecmo (extracorporeal membrane oxygenation) in the intensive care unit (icu), a bio-medicus life support catheter and introducer was inserted and a broken defect was observed in the most proximal part of the hard plastic connector to the tubing.The cannula was not changed due to the patient¿s circumstances, and connecting the tubing did not cause any problems as the connector was secured with a cable tie.The device was used to complete the procedure.No patient complications have been reported as a result of this event.Medtronic received additional information that the cannula was not heated or cooled prior to use.The cannula was delivered in a back pack as they had to cannulate in another hospital.The damage was not in the location of the sutures.The customer cannulated by placing the white introducer inside without applying any special force.When they were about to connect the tubing, they noticed a clear break in the most proximal part of the cannula, which appeared whitish.The break did not reach the end.Since there was a margin that was not broken, they decided to connect the tubing and proceed with ecmo, and then a more distal tie was placed.It continued to be used in the patient without any issues.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed evidence of damage/crack in the connector.The reason for the return was confirmed.Correction h6 (patient codes (ime/annex e), h6.1 (device codes (fdd/annex d) and additional codes imf (annex f) health impact: these codes have been updated.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 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: 24188188
• Report Number: 9617601-2026-00628
• Device Sequence Number: 9766886
• Product Code: DWF
• UDI-Device Identifier: 00763000615482
• UDI-Public: (01)00763000615482(17)280130(10)230540834(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LS96550-017
• Device Catalogue Number: LS96550-017
• Device Lot Number: 230540834
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown