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

Model Number AC3200

Device Problems Display or Visual Feedback Problem (1184); Inflation Problem (1310); Device Difficult to Setup or Prepare (1487)

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

Event Date 05/27/2022

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

During a procedure an attempt was made to use two everest inflation devices.The devices were removed from the packaging per ifu with no issues noted.The devices were inspected with no issues noted.The devices were prepped per ifu with no issues noted.It was reported that inflation difficulties were encountered.The issue did not occur during prep.During use in the patient, it was detailed that the devices were stuck at level 8 in the chamber with manipulation difficulties encountered.The in-deflator was not connected to a mating device when the issue occurred.The patient was reported to be alive with no injury.

Manufacturer Narrative

Additional information: level 8 refers to the number level on the syringe plunger.When the plunger was pull backed some resistance was encountered.The dif ficulties were encountered at both inflation and deflation.The everest devices were connected to a non-medtronic pre-delivery balloon.The balloon fully inflated.A 50:50 concentration of contrast / saline was used.The everest gauge was reported as normal.Image review: one image was provided for review.The image was of the body of the syringe with an arrow pointing to the plunger tip.The plunger was in position at the 8cc mark on the syringe body.One video file was also provided for review.The video was of the the syringe body.In the video it appeared that the operator was having issues retracting and advancing the the plunger.The plunger was first in position at the distal of the syringe body.When attempting to retract the plunger it appeared to be stuck.The plunger then appeared to retract after some effort.After retracting the plunger, the operator attempted to push the plunger distally.The plunger appeared to get stuck at 8cc point on the syringe body before it advancing distally.The operator retrected and advanced the plunger a number of times and there appeared to be resistance when performing this action.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: one everest inflation device returned for analysis.No damage was noted to the syringe body, tube joints or manometer housing.When retracting and advancing the piston/plunger, resistance was met at level eight on the syringe.A noticeable effort was required to retract and advance the piston/plunger past the point of resistance.As received the gauge needle was at approx.0 atm.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.14 atm.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.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.

Manufacturer Narrative

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.

Event Description

During a procedure an attempt was made to use two everest inflation devices.The devices were removed from the packaging per ifu with no issues noted.The devices were inspected with no issues noted.The devices were prepped per ifu with no issues noted.It was reported that inflation difficulties were encountered.The issue did not occur during prep.During use in the patient, it was detailed that the devices were stuck at level 8 in the chamber with manipulation difficulties encountered.Level 8 refers to the number level on the syringe plunger.When the plunger was pull backed some resistance was encountered.The difficulties were encountered at both inflation and deflation.The in-deflator was not connected to a mating device when the issue occurred.The everest devices were connected to a non-medtronic pre-delivery balloon.The balloon fully inflated.A 50:50 concentration of contrast / saline was used.The everest gauge was reported as normal.The patient was reported to be alive with no injury.

• 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: 14712509
• MDR Text Key: 295246496
• Report Number: 1220452-2022-00049
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00643169843035
• UDI-Public: 00643169843035
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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,Followup,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: AC3200
• Device Catalogue Number: AC3200
• Device Lot Number: 60348554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• 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