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	LS96360-025
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
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
Medtronic received information that during use of a bio-medicus life support cannula, it was reported that upon cannulating the patient via the left groin using a cut down technique the clinician could not remove the introducer from the catheter body ( ls96360-025 multistage drainage catheter).The clinician could only retract the introducer by approximately 10cm.The decision was made to replace the cannula with another ls96360-025 and the exact same issue resulted.The clinician then decided to cannulate using a livanova rap cannula and this was successful.The patients vessel was dilated using the livanova access kit to 24fr dilation prior to cannulation.The cannula body was wetted out using saline prior to introducing the white introducer (customer protocol).The customer asked if the elasteon material of the biomedicus life support catheter has any impact on friction between the catheter body and the white introducer material.(please detail the introducer material in the report).The customer asked for a detailed check on any manufacturing variance on the cannula body and the white introducer.Are they within specification and what is that specification (was one at the top end and the other at the bottom end to contribute to a tight fit).Please note the first catheter's being returned appears to have a textured feel to the body of the white introducer - the second catheter currently retained by the customer has a completely smooth feel.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows no outward signs of any damage.The introducer was inserted and removed from the cannula several times with no issues observed.The introducer od was measured using a keyence scope and the cannula id was measured using a pin gage.Introducer od was measured to be 0.279 inches, the specification m725652b001 has the od to be 0.281 +0.005 / -0.003 inches.Cannula id was measured to be 0.268 inches, the specification m970540axxx has the id to be 0.267 to 0.276 inches.Reason for return was not confirmed.Additional info b5: medtronic received additional information that the second cannula reported had no noticeable product imperfections or damage.Additional info h6: updated the annex b and annex c codes 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 devices were used for a cardiopulmonary bypass (cpb) procedure.Correction d2 (product code), d3 (mfr name), and d3.6 (postal code): these fields have been updated.Correction section e initial reporter: the street 1 field has been updated.Correction g4.4 (pma / 510(k) #): this field 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, 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: 20759175
• Report Number: 9612164-2024-05507
• Device Sequence Number: 18514811
• Product Code: DWF
• UDI-Device Identifier: 00763000615581
• UDI-Public: 00763000615581
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201100
• 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): 04/01/2025

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: 07/19/2026
• Device Model Number: LS96360-025
• Device Catalogue Number: LS96360-025
• Device Lot Number: 226968947
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 03/06/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 02/10/2025; 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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