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

Model Number AC2200

Device Problems Display or Visual Feedback Problem (1184); Defective Device (2588)

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

Event Date 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

Product analysis: 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.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.15 atm.Upon release of pressure the gauge needle dropped to approx.2 atm.When vacuum was applied, the gauge needle did not move into the red "vac" reading, dropping to approx.1 atm.It was also noted that 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.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.No damage was noted to the device packaging.The device was removed from the packaging and prepped per the ifu with no issues noted.The device was inspected with no issues noted. it was reported that there was a manometer issue.It was detailed that the needle jumped suddenly during inflation.The issue occurred during balloon inflation while pressure was applied.Initially the needle didn't react, however, afterwards it jumped from 0 to 12/14 atm.The reading returned to 0 atm when negative pressure was drawn and the balloon deflated.A stopcock was not connected between everest and balloon.The balloon was being used in the patient when the issue occurred.The procedure was completed with the same balloon.The patient is alive with no injury.

Manufacturer Narrative

Product analysis: during analysis on the manometer in the manufacturing site, discoloration was observed on the surface of the filter, indicating that a foreign media came into contact with the gauge.It was also noted that the device had a resistance during the retracting and advancing of the piston/plunger.Based on the evaluation of the returned gauge by the manufacturing site it was concluded that the presence of a foreign media led to the failure of the gauge.Due to the results of the testing, the manufacturing site believes that the presence of a foreign media along with the retracting and advancing of the piston can cause an over pressure occurrence.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
• 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: 15519248
• MDR Text Key: 301276961
• Report Number: 1220452-2022-00069
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00643169843011
• UDI-Public: 00643169843011
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K942269
• 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
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AC2200
• Device Catalogue Number: AC2200
• Device Lot Number: 60364604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• 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