MAUDE Adverse Event Report: PERFUSION SYSTEMS AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	20014L
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
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 dlp aortic root cannulae with a vent line, it was reported that the patient had surgery for a replacement aortic valve with a 23mm mechanical heart valve.The patient had a thyectomy repair aortic aneurysm with a 30mm straight gelweave graft with a cardiopulmoary bypass.The patient had an encompass maze procedure and a ligation of the left atrial appendage with a 40mm atriclip.The echocardiography transesophageal aortic root cannula was being removed from the patient and the catheter tip broke off possibly inside the patient.It was unclear whether it broke off inside the aorta or within the paracardial space.The patient was on 16 meq, acetylsalicylic acid (asa) 81mg, coumadin, potassium chloride (klor-con) per sliding scale, 40mg of lasix iv bid, 25mg of lopressor, 90mg of mestinon, multiple organ dysfunction (mod) pain, 1200mg of mucinex, 1-2 tablets of norco, q6hr prn novolog insulin, 200mg of pain amiodrone, 40mg of prilosec, 2 tablets of senokot and 650mg of tylenol q4hr prn.The use of the device was unspecified.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Additional information b5: medtronic received additional information that there was no impact to the patient before discharge and the customer had not been aware of any impact either.Medtronic received additional information that the cannula was not used after the issue was identified.The cannula was not replaced as the surgery was completed.It was stated that it is unknown if the piece fell into the patient and it was not recovered.Correction b5: medtronic received information that during use of a dlp aortic root cannula with a vent line, it was reported that the patient had surgery for a replacement aortic valve with a 23mm mechanical heart valve.Correction e4 (rpt.Sent to fda?): this field has been updated to yes.Correction g2 (report source): user facility has been selected.Correction g3 (date mfr rec): the date provided in the initial report 2184009-2024-00435 should have been 15 july 2024.Correction h10: the medwatch number has been 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.
Additional Manufacturer Narrative
Additional information b5: medtronic received additional information that the cannula tip is not radiopaque therefore it would not show up on any imaging and the tip did not show up on subsequent imaging.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: AORTIC ROOT ANTEGRADE ANTEGRADE 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: 19836677
• Report Number: 2184009-2024-00435
• Device Sequence Number: 20802653
• Product Code: DWF
• UDI-Device Identifier: 00613994495556
• UDI-Public: 00613994495556
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K810548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2024

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 Model Number: 20014L
• Device Catalogue Number: 20014L
• Device Lot Number: 2023120495
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 10/22/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/25/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• 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 Age: 43 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Hispanic