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

Model Number	LS96555-021
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a bio-medicus life support cannula, it was reported that when ls arteriovenous cannula ls96555-021 was being used in extracorporeal membrane oxygenation (ecmo) patient, it was found that there were cracks at the tail of the cannula, which affected the treatment of ecmo patient.The use of the device was unknown.There was no adverse patient effect associated with 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
Medtronic received additional information that there was no damage to the packaging, and other devices in the same box/shipping container were not damaged.Additional info h6: fdc code updated additional info d4: lot number added, expiration date added, and the udi added additional info h4: manufacturing 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; 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: 19307499
• Report Number: 9612164-2024-02287
• Device Sequence Number: 7332516
• Product Code: DWF
• UDI-Device Identifier: 00763000615505
• UDI-Public: 00763000615505
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201057
• Number of Events Summarized: 1
• Summary Report (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): 06/10/2024

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: 09/14/2026
• Device Model Number: LS96555-021
• Device Catalogue Number: LS96555-021
• Device Lot Number: 227361227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2023
• 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