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

Model Number AC3200

Device Problems Corroded (1131); Display or Visual Feedback Problem (1184); Inflation Problem (1310); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2022

Event Type  malfunction  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

An attempt was made to use one everest inflation device.On physical observation there was no defect on the manometer.It was reported that when attempts were made to inflate the indeflator, the pressure changed from 2 atm to 6 atm.There were a few attempts to inflate the indeflator, but the same issue happened on each attempt.The inflation pressure never proceeded to more than 6 atm.The pressure needle returned back to zero when pressure was released.The device that was connected to the everest was being used in the patient when the issue occurred.There was no balloon burst as a result of this event as the pressure never went above 6 atm.The device was changed to a new indeflator with no issue.The patient is alive with no injury.

Manufacturer Narrative

Product analysis #285126929:one still image was provided for review.The image provided appears to show an everest inflation device in a biohazard bag.Note on bag appears to read: ac3200 (ntf) 2 atm - 6 atm.Image provided could not confirm display issue product analysis #285115559:one everest inflation device returned for analysis.No damage was noted to the syringe body, tube, joints or manometer housing.As received the gauge needle was at approx.1.5 atm.Using an inhouse stopcock, the device was pressurized with water.Using an inhouse stopcock, the device was pressurized with water.The gauge needle moved steadily to 30 atm; the device was pressurised for a minimum of three minutes and failed to hold pressure within specification of max 10% loss, dropping to approx.25 atm.Upon release of pressure the gauge needle dropped to approx.3 atm.When vacuum was applied, the gauge needle dropped to approx.1atm.Additional information: the device was inspected before use, with no issues noted.The device was prepped as per the ifu with no issues noted.There was no resistance noted while holding the trigger and pulling back the piston.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: annex d code medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis visual inspection of the returned gauge identified discoloration on the socket.Functional testing found the unit to be out of tolerance.Liquid was observed to be bubbling out of the unit.The gauge did not reach full travel.The gauge was disassembled to inspect the internal components.During the removal of the case corrosion was observed on the case tabs, staining and corrosion were present on the socket inspection of the hairspring assembly found the hair spring sticking.Visual inspection found the hairspring to be deformed.Based on the evaluation of the returned gauge, wika confirmed that there was damage to the movement hairspring.Wika concluded that the unit was subjected to moisture ingress which led to the presence of corrosion on the surfaces which led to the failure of the gauge.The movement hair spring was no longer functioning.The pointer would not reach full scale.Wika confirmed that the gauge was out of the specified tolerance.Visual inspection found the hair spring to be deformed.Correction: annex c code.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVEREST INFLATION DEVICE 30ATM
• Type of Device: 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: 16173285
• MDR Text Key: 308753034
• Report Number: 1220452-2023-00013
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00763000338190
• UDI-Public: 00763000338190
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K960983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AC3200
• Device Catalogue Number: AC3200
• Device Lot Number: 60406514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1