MAUDE Adverse Event Report: MEDTRONIC, INC EVEREST; SYRINGE, BALLOON INFLATION

Model Number AC3200

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An attempt was made to use an everest inflation device.There was no damage noted to the device packaging.There were no issues noted when removing the device from the packaging.It was reported that a piston/knob issue was experienced.There were difficulties in pulling the trigger to release the locking mechanism during preparation.It was later reported that when an attempt was made to expand a non-medtronic (mdt) balloon catheter, the everest inflation device r esponded but the scale did not rise.The gauge did not move, the needle remained at zero.A balloon burst did not occur because of this event.There was no stopcock connected between the everest device and the non-mdt balloon catheter.The non-mdt balloon catheter was being used in the patient when the issue occurred.No patient injury was reported.

Manufacturer Narrative

Product analysis: one everest inflation device was received for analysis no damage was noted to the syringe body, tube joints or manometer housing.As received the gauge needle was at 0atm.Using an inhouse stopcock, an attempt was made to pressurize the device with water.The gauge needle did not move immediately; however, it then moved slowly to 11atm and would not advance further.When vacuum was applied, the needle remained at 11atm.The water was removed from the device and the needle on the gauge remained at 11atm.No issues noted to functionality of piston/knob or trigger.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

Further product analysis summary: one gauge was returned for a slow pointer.The pointer failed to reach full scale.The pointer stopped at 11 atm.Visual inspection of the gauge observed that the pointer was outside of the zero box.Glue residues were observed on the process connection threads indicating the gauge was in service.Discoloration was also observed on the socket.Moisture residues were observed on the hairsprings.Disassembly of the gauge identified residues on the lower movement plate.The residue was confirmed to be colophonium.Based on the evaluation of the returned gauge the manufacturer believes that the gauge was subjected to a heat cycle, which liquefied the colophonium allowing it to come into contact with the pinion shaft.It is therefore concluded that the gauge was subjected to a heat cycle, which led to the liquidation of the colophonium.In the liquefied state, the colophonium came into contacted the pinion shaft.This led to the sluggish pointer travel, and eventually led to the failure of the gauge.The manufacturers soldering process socket to bourdon tube and bourdon tube to end piece, was reviewed but was unable to reproduce the failure during the soldering process.The application of heat to a soldered system was able to duplicate the failure.The colophonium liquefied and it recrystallized as it cooled.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
• Type of Device: SYRINGE, BALLOON INFLATION
• 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: 12778643
• MDR Text Key: 280524599
• Report Number: 1220452-2021-00070
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: AC3200
• Device Catalogue Number: AC3200
• Device Lot Number: 60286719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 03/02/2022; 06/22/2022
• Supplement Dates FDA Received: 03/21/2022; 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• 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