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

Catalog Number AC3200

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the stop cock from the everest kit and mating devices used in the case were returned for analysis with the inflation device.The everest was connected to the stopcock and the stopcock to one of the non-medtronic balloon luers and a non-medtronic syringe was connected to the other luer of the stopcock.As received the gauge needle is at -0atm-.The plunger was pulled back, with fluid in the everest syringe body.The everest syringe body, tube and lure rotator/connector all appear undamaged and without defect.The connections were taken apart and pressure/inflation function was tested on the returned everest inflation device and the device holds full pressure for 3 minutes with no more than 10% loss meeting specification.No leaks were detected during pressure testing.The plunger was pulled back and the needle returned to red as required.The everest device was tested for needle functionality at different pressure values resulting in no failures.

Event Description

An everest inflation device was being used during a shunt pta procedure (i.E., vascular access intervention therapy).One 4.0x40mm non medtronic balloon and one 5.0x40mm non-medtronic balloon were used during this procedure also.The everest inflation device was removed from packaging per ifu.The device was inspected with no issue.During balloon inflation, the hand of the everest¿s pressure gauge did not move when fluoroscopy showed that the balloon was inflated.After several attempts, the everest worked as usual.Patient status is alive - no injury.

Manufacturer Narrative

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

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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6539518
• MDR Text Key: 74255981
• Report Number: 1220452-2017-00033
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K960983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2017

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: 10/08/2018
• Device Catalogue Number: AC3200
• Device Lot Number: 51014120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: 06/21/2017; 06/21/2017
• Supplement Dates FDA Received: 07/21/2017; 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2016
• 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