MAUDE Adverse Event Report: MEDTRONIC MEXICO BIO-MEDICUS LIFE SUPPORT TM; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	LS96555-023
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
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 an extracorporeal membrane oxygenation (ecmo) retrieval procedure, after cannulating the right femoral vein, the bio-medicus life support cannula's connector was found to be cracked and deemed unsafe to use.The clinical team noted that the cannula "didn't click like the other one." it was also reported that the haemostasis cap was not used during the assembly of the cannula.The investigation into potential damage by the clinical team during insertion was inconclusive, and it was suggested that the translucent haemostasis cap might have been discarded in error prior to assembling the introducer into the cannula.The customer expressed concern that the translucent haemostasis cap's color matched the packaging, potentially leading to oversight.A new cannula was placed into the patient without harm.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows evidence of damage/crack in the connector.The hemostasis cap was not returned.Reason for return was confirmed.Additional information b5: medtronic received additional information that there was minimal patient blood loss as a result of the crack.There was no unplanned blood transfusion required.The customer used the initial insertion site for the replaced cannula.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 h6.4 eval code conclusion (fdc/annex d): this field was 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; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21166158
• Report Number: 9612164-2025-00289
• Device Sequence Number: 17212308
• Product Code: DWF
• UDI-Device Identifier: 00763000615512
• UDI-Public: 00763000615512
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 03/25/2025

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: LS96555-023
• Device Catalogue Number: LS96555-023
• Device Lot Number: 228859073
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 01/21/2025; 03/05/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/18/2025; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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