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 Problems Perforation (2001); No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician intended to use an everest inflation device to treat a lesion in the diagonal branch with 60% stenosis.The device was removed from packaging per ifu.The device was inspected with no issues.The device was prepped per ifu.The device was connected to a balloon catheter.It is reported that no signal of increasing pressure displayed on the device and the balloon burst in the artery.No patient injury is reported.

Manufacturer Narrative

Upon review of the cine images it was confirmed that a perforation had occurred.Cine images analysis summary: after initial stent deployment in the lad kissing balloon technique (kbt) was performed between the diagonal and the main vessel.The kbt appears to have been completed with a low profile outer diameter balloon.After kbt there is evidence of contrast exiting the vessel indicating that the balloon has burst.This also suggests that there was perforation to the vessel.This perforation to the vessel was treated with repeat lesion ballooning and stent deployment.No permanent injury to the vessel is apparent.The root cause of the perforation is not evident from the images provided.Product analysis summary: the device was returned for analysis.As received the gauge needle was at 0atm.The everest syringe body, tube and lure rotator/connector all appear undamaged and without defect.Closer visual inspection detected no damage to the gauge housing or the syringe body.During functionality testing the device aspirated water with the needle remaining at 0atm failing to return to vacuum.The device was pressurized while turning the knob one full turn, the needle remained at 0atm, no movement detected on the needle.Another in-house functional everest was connected side by side with returned everest gauge and the returned gauge needle remained at 0atm while the in-house everest needle moved freely.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.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: 6964690
• MDR Text Key: 90654913
• Report Number: 1220452-2017-00105
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00643169621916
• UDI-Public: 00643169621916
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2019
• Device Catalogue Number: AC3200
• Device Lot Number: 51026713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR