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 03/30/2017

Event Type  malfunction  

Event Description

The physician intended to use an everest inflation device.The device was removed from packaging per ifu, inspected and prepped; no defects noted.It is reported that during use when pressure was applied to the device, the needle did not move.Inflation device was attached to the non mdt balloon hub and inserted into the patient vessel.The nurse applied pressure to the inflation device that was prepared as per instructions for use.As the nurse was turning the handle, the pressure needle on the gauge remained at zero.It did not register pressure.An x-ray image was taken and the balloon had burst.However, the vessel didn't rupture or dissect.A new ac3200 and balloon were used.The balloon was able to be inflated and the case completed successfully.No patient injury reported.

Manufacturer Narrative

Product analysis: as received the gage needle was at 0 atm.The everest syringe body, tube and lure rotator/connector all appear undamaged and without defect.Closer visual inspection to the gauge detected no damage to the gauge housing or the syringe body.During functionality testing the device aspirated water with the needle remaining at 0 atm failing to return to vacuum.The device was pressurized while turning the knob one full turn, the needle remained at 0 atm, no movement detected on the needle.The gauge was removed from the syringe body, closer inspection of the bore detected glue like material around the bore at the bottom on the metal filter.Further analysis using micro-fourier transform infrared spectroscopy (ftir) concluded that the bulk of the blockage material was found to be a polyester-based polyurethane.This blockage was holdings back water under pressure within the gauge.A small mass of biological material, consisting of proteins and polysaccharides, was found in conjunction with the bulk of the polyurethane.The material composition was found polyester-based polyurethane, such compounds may be used as adhesives.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: 6525272
• MDR Text Key: 73785648
• Report Number: 1220452-2017-00032
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00643169014800
• UDI-Public: 00643169014800
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/10/2017

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: 05/14/2018
• Device Catalogue Number: AC3200
• Device Lot Number: 50985924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 08/10/2017; 08/10/2017
• Supplement Dates FDA Received: 09/07/2017; 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2016
• 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
• Patient Age: 55 YR