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 Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
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 prior to use of a bio-medicus life support cannula, upon opening the product the customer experienced difficulty with the introducer, which could not be removed from the catheter body due to it being sticky/high friction at a specific point. the cannula body was wetted with saline prior to introducing the white introducer, following customer protocol. the introducer could only be retracted by approximately 7-10 cm before sticking. the device was replaced with another manufacturer's product. there was no patient involvement.
Additional Manufacturer Narrative
B.5.Medtronic received additional information that upon visual inspection of the cannula, the customer noted that when the introducer was removed from the cannula, the cannula tip was not a perfect circle.The external packaging and the protective tube holding the cannula for shipping did not show damage.The customer decided to check other multistage femoral venous cannula in their stock.They observed the same ¿non-perfect circle¿ on the cannula body tip on most of the cannulae in their stock.They opened two expired devices and checked if the introducer was sticky upon removing around 7-10cm.It was confirmed they were sticky.This was noted on the extracorporeal membrane oxygenation (ecmo) life support range as well as the bio-medicus next gen multistage cannulae.They also removed from the hospital an expired multi and also an expired old gen bi-caval and they were both ¿slightly sticky¿ at the 7-10cm area when removing the introducer.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 received additional information that upon visual inspection of the cannula, the customer noted that when the introducer was removed from the cannula, the cannula tip was not a perfect circle.The external packaging and the protective tube holding the cannula for shipping did not show damage.Medtronic received additional information that no tips were obstructed.Once the introducer was inserted, the cannula appeared normal.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 showed no outward signs of any damage.The introducer outer diameter (od) was measured using a keyence scope and the cannula tip inner diameter (id) was measured using a plug gage.The introducer od was measured, and it was within specification.The cannula tip id was measured, and it was within specification.The introducer was inserted and removed several times with no issues noted.The reason for return was not confirmed.Correction d3 (mfr name) d3.6 (postal code): these fields have been updated.Correction additional codes (imf (annex f) health impact): this code has 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, 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: 20890276
• Report Number: 9612164-2024-05875
• Device Sequence Number: 7842986
• Product Code: DQY
• UDI-Device Identifier: 00763000615574
• UDI-Public: 00763000615574
• 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,Followup
• Report Date (Section B): 03/27/2025

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 Expiration Date: 06/05/2026
• Device Model Number: LS96360-023
• Device Catalogue Number: LS96360-023
• Device Lot Number: 226707373
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 01/14/2025; 03/03/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/10/2025; 02/11/2025; 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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