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

Model Number AC3200

Device Problems Deflation Problem (1149); Display or Visual Feedback Problem (1184); Inflation Problem (1310)

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

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 during a procedure.The device was inspected with no issues noted.The device was prepped per ifu with no issues.The alleged issue did not occur during prep.It was reported that inflation and deflation difficulties occurred in the patient.There was an inability to inflate or deflate.The everest device was connected to a stent when the issue occurred.There was no stopcock attached.The issue was noted after connecting to the stent and pulling the inflation device handle back to go to the negative position, then releasing from negative to inflate the stent.The device handle was turned but there was no inflation, and then suddenly the pressure needle moves quickly to read a high pressure but yet the stent balloon was not inflated at any time.The everest was disconnected from the stent, with no issue noted as regards the stent.The device had been used previously during the case to inflate a balloon with no issue.A new everest inflation device was opened and used with no further issue noted.No patient injury reported.

Manufacturer Narrative

Product analysis summary: one everest inflation device returned for analysis.No damage was noted to the syringe body, tube, joints, or manometer housing.No damage noted to the stopcock.As received the gauge needle was at approx.0 atm.Using the returned stopcock, the device was pressurized with water.The gauge needle moved steadily to 30atm, and the device held pressure for a minimum of three minutes meeting specification.Upon release of pressure the gauge needle dropped to approx.0 atm.When vacuum was applied, the gauge needle moved into the red "vac" reading.No observable causes of failure to maintain pressure were noted during testing.An in-house euphora device was inflated and deflated with the everest device with no issues noted.Additional information: d.Suspect medical device - lot number provided.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: 18333572
• MDR Text Key: 330579133
• Report Number: 1220452-2023-00104
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00763000338190
• UDI-Public: 00763000338190
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 60427097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2023
• 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