MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HOT AXIOS STENT AND DELIVERY SYSTEM

Model Number HXS-10-10

Device Problem Retraction Problem (1536)

Patient Problem Internal Organ Perforation (1987)

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

The pt with a complicated gallbladder drainage was fine after surgery.She had extensive cancer that was diagnosed just before the drainage with carcinosis detected during the surgical operation for the gallbladder.I check the scope with which we performed the procedure and there was a problem with the elevator that was not coming back to the initial position.This might have contributed/caused the problem with the stent with the problem of release of the proximal flange that could not released even though all the steps were done correctly.Hope this info will help to clarify what happened and a soon as we will receive the box we will send back the scope for further checking.

Event Description

Occurred in (b)(6).The pt was female.Physician stated that while performing a gallbladder drainage case with hot axios, he was unable to deploy the second flange.He felt lots of resistance as he was positioning the catheter for second flange deployment after successful access to the gb and first flange deployment.He used endoscopic guidance for second flange deployment and after moving the catheter, with resistance, such that he could see the black marker in the gi lumen, he moved the stent deployment hub to the top of the handle, but it did not release the stent.He eventually removed the stent and catheter from the pt, leaving a perforation in the gall bladder.He sent the pt to surgery.He states that post operatively, the pt is doing well.She remains hospitalized on (b)(6) secondary to advanced cancer.

• Brand Name: HOT AXIOS STENT AND DELIVERY SYSTEM
• Type of Device: AXIOS STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; mountain view CA
• Manufacturer Contact: david hasker ; 453 ravendale drive; suite h; mountain view, CA 94043 ; 6509619900
• MDR Report Key: 5057596
• MDR Text Key: 25225575
• Report Number: 3008516478-2015-00005
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: HXS-10-10
• Device Lot Number: FGS00264
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention