MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS NG 21 FR VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	96670-121
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows no outward signs of any damage.A 0.38" guidewire was inserted into the tip of the device and slid in with no issues.The same guidewire was inserted into the hub end and it would not fit.The id of the cannula hub was measured against the specification using a keyence vision scope.The id of the tip of the device was measured against the specification using keyence vision scope.Introducer hub id = measured in 2 separate depths, 0.035 and 0.026 inches, specification is 0.043 +/- 0.003 inches.Appears to be evidence of flash.Introducer tip id = 0.039 inches, specification is 0.040 +0.002 / - 0.001 inches.Reason for return was confirmed.This regulatory report is being submitted due to retrospective review through capa 624392.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 prior to use of a bio-medicus nextgen femoral bi-caval venous cannula, when planning on introducing the device, the customer realized that the guidewire would not pass through the introducer hole as there seemed to be a block inside the introducer.The device was replaced to complete the procedure.There was no patient involvement, so no adverse effect occurred.

• Brand Name: BIO-MEDICUS NG 21 FR VENOUS CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20901047
• Report Number: 2184009-2024-00799
• Device Sequence Number: 14715420
• Product Code: DWF
• UDI-Device Identifier: 00643169025974
• UDI-Public: 00643169025974
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 12/11/2024

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: 07/05/2026
• Device Model Number: 96670-121
• Device Catalogue Number: 96670-121
• Device Lot Number: 224626242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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