MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV BIO-MEDICUS NG ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	96570-115
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Death
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 use of a bio-medicus cannula, there was a sudden break at the lateral branch circulation.The use of the device was unspecified.It was unknown if there was any patient involvement or complications as a result of the event.
Additional Manufacturer Narrative
Additional info b5: medtronic received additional information that the leak came from the cannula.The cannula was not heated or cooled prior to use.The amount of blood loss was too great to provide data.A transfusion was required as a result of this leak.There were 2 units of blood (250-300ml) transfused.Medtronic received additional information that the cause of death and if patient's death believed to be linked to the performance of cannula are both yet to be clarified.Medtronic received additional information that the cannula was in use from (b)(6) 2025 (25 days).Correction h6: updated the annex a and annex e codes correction b5: it was reported that there was a sudden break at the lateral branch circulation involving the bio-medicus cannula.The cannula was not replaced to complete the procedure.The doctor asked the family to make the decision directly.The patient passed away.Correction d4: updated the model number, catalog number, lot number, udi, and device expiry date correction e2: updated to yes correction e3: occupation updated to physician.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 customer used a syringe to plug the port when it broke.Correction d3 (mfr name), d3.6 (postal code), d4.5 (unique identifier (udi) #): these fields 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 NG ARTERIAL CANNULA
• 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: 21641315
• Report Number: 9612164-2025-01394
• Device Sequence Number: 7700860
• Product Code: DWF
• UDI-Device Identifier: 00763000116071
• UDI-Public: (01)00763000116071(17)280617(10)229100000
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K142673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2025

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: 96570-115
• Device Catalogue Number: 96570-115
• Device Lot Number: 229100000
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: 03/20/2025; 06/10/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/10/2025; 07/04/2025
• Date Device Manufactured: 06/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 58 YR
• Patient Sex: Male