MAUDE Adverse Event Report: MEDTRONIC, INC EVEREST INFLATION DEVICE 30ATM; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number	AC3200
Medical Device Problem Codes	Deflation Problem (1149); Display or Visual Feedback Problem (1184); Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
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
An attempt was made to use one everest inflation device during a procedure.The device was inspected with no issues.The device was prepped per ifu with no issues.The alleged issues occurred during prep, and when the everest was connected to a mating device inside the patient.It was reported that there was a manometer issue, and the manometer was damaged.It was detailed that during prep the manometer did not give proper pressure.It was than attempted to deflate the balloon in the patient but the balloon did not deflate completely.The issue was noticed during a procedure in the patient.There was no consequence for the patient.
Additional Manufacturer Narrative
Additional information: it was later reported that the manometer issues were detected while inflating the non-medtronic balloon while the device was being used in the patient.A stopcock was also connected between the everest and the balloon.The needle remained stationary and did not move when pressure was applied however the balloon did inflate.When it was noted that the everest was not displaying the nominal inflation pressure, the device was replaced by another everest device.The patient is well and there was no injury or damage reported to the patient.A.Patient information and patient's details included.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: lot number 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.
Additional Manufacturer Narrative
Product analysis summary: a stopcock was attached to the device on return, which was removed with no issues.The needle was at approx.0atm.Visual inspection of the returned device showed a crack was on the plunger tip when the piston was retracted.Due to the crack on the plunger tip, it was not possible to aspirate liquid into the syringe correctly, affecting ability to set up and prepare device.When using the everest to inflate an in-house poba the balloon inflated however the everest failed to hold pressure.Also, it was not possible to apply the vacuum and air was observed entering the syringe chamber, however the balloon deflated with no issues.The issues occurred due to the crack on the plunger tip.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: EVEREST INFLATION DEVICE 30ATM
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18967198
• Report Number: 1220452-2024-00019
• Device Sequence Number: 6807379
• Product Code: DTL
• UDI-Device Identifier: 00763000338190
• UDI-Public: 00763000338190
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K153038
• 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,Followup
• Report Date (Section B): 06/12/2024

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: 03/15/2025
• Device Model Number: AC3200
• Device Catalogue Number: AC3200
• Device Lot Number: 60445422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 05/08/2024; 05/29/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/23/2024; 05/24/2024; 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 78 KG