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

Model Number	AC3200
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An attempt was made to use one everest inflation device during a procedure.The patient was transferred to the cath lab for emergency percutaneous coronary intervention (pci).The everest device was inspected before use with no issues noted.During the operation the everest inflation device was being used for balloon dilation.The device was directly connected to a medtronic balloon.It was reported that after multiple attempts the inflation pressure could not be reached.There was a display issue noted.When rotating and pressurizing, the pressure pump pointer did not change.The needle did not move at all when pressure was applied.The device that was connected to the everest was being used in the patient when the issue occurred.A balloon burst did not occur because of the event.A new inflation device was requested, and the operation continued successfully without causing adverse consequences to the patient.The patient returned to the ward after the operation.No patient injury reported.
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.
Additional Manufacturer Narrative
Additional information: one sprinter legend coronary balloon was being during the procedure.The sprinter legend balloon was inspected before use with no issues noted.Negative prep/purging was performed on the sprinter legend device prior to use with no issues noted.Resistance was not noted while advancing the sprinter legend balloon to the lesion.The sprinter legend was being used to pre-dilate the lesion.The everest device was directly connected to the medtronic sprinter legend balloon.There was no change in the pressure value.The sprinter legend balloon was not moved or repositioned while inflated.There was zero inflation of the balloon.A new medtronic inflation device was used as the replacement.The same sprinter legend balloon was used with the replacement inflation device, with no issue noted.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: annex d code 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.

• 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: 18938895
• Report Number: 1220452-2024-00017
• Device Sequence Number: 6827183
• Product Code: DTL
• UDI-Device Identifier: 00763000338190
• UDI-Public: 00763000338190
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2024

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: 05/02/2025
• Device Model Number: AC3200
• Device Catalogue Number: AC3200
• Device Lot Number: 60457387
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 03/25/2024; 04/08/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/03/2024; 04/09/2024
• Date Device Manufactured: 05/03/2023
• 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: 62 YR
• Patient Sex: Female