MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV BIO-MEDICUS NG 17 FR VENOUS CANNULA; CATHETER, PERCUTANEOUS

Model Number	96670-117
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of these bio-medicus nextgen multi-stage femoral venous cannulae, the white mandrel did not slide into the cannulae, preventing it from being pulled out.The devices were replaced.No patient complications have been reported as a result of 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows no outward signs of any damage.The introducer od was measured using a keyence scope and the cannula tip id was measured using a plug gage.Introducer od was measured to be 0.178 inches, the specification (b)(4) has the od to be 0.179 +0.003 / - 0.002 inches cannula tip id was measured to be 0.175 inches, the specification (b)(6) has the id to be 0.170 to 0.177 inches the introducer was inserted and removed several times with no issues noted.Reason for the return was not confirmed.Additional information b5.Medtronic received additional information that the customer returned a dlp aortic root cannulae with vent line along with the two bio-medicus nextgen multi-stage femoral venous cannulae.Analysis of the third device showed a blockage in the vent line.H6.3 eval code result (fdr/annex c): this field was added.D3.Mfr name & d3.6 postal code: these fields were corrected.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 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 17 FR VENOUS CANNULA
• 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: 22395289
• Report Number: 9612164-2025-03282
• Device Sequence Number: 21129926
• Product Code: DQY
• UDI-Device Identifier: 00643169025998
• UDI-Public: (01)00643169025998(17)270421(10)226412592
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K180453
• 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): 08/22/2025

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: 96670-117
• Device Catalogue Number: 96670-117
• Device Lot Number: 226412592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 07/30/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/31/2025; 08/22/2025
• Date Device Manufactured: 04/21/2023
• 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