MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00534350
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation analysis: an advanix rx bili preload db was returned for analysis.A visual evaluation of the returned device revealed that kinks were found in the guide catheter distal section, additionally, it was found the stent was damaged (torn and kink) and the stent suture hole and push catheter hole were found torn, however, the suture did not have any visual damaged.A functional test was performed and the pull wire/guide catheter was fully retracted and the stent was able to be deployed.Based on the product analysis, the issue occured during the procedure, inside the patient, additionally, it was reported that there was "common bile duct stenosis" during procedure, it is important to mention that this anatomical factor can cause resistance and/or friction during the deployment of the stent, the device may become difficult unable to be properly/smoothly advanced/handled and at the same time impacting the functionality of the device generating the observed guide catheter bent/kink, the continued attempts to retract the guide catheter or force applied to the device in order to release the stent in addition to the found bent/kinks can result in the found suture push hole and the stent suture hole torn, also, the found stent damaged (torn and kink).Therefore, 'adverse event related to patient condition' is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician attempted to deploy the stent, severe resistance was noticed and the stent failed to deploy.Reportedly, the duct was dilated because of stones.Another advanix-naviflex stent was opened and successfully completed the procedure.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results; stent damaged.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9481572
• Report Number: 3005099803-2019-06049
• Device Sequence Number: 2313744
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0023924827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR