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

Model Number	M00534320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filled.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during endoscopic retrograde cholangiopancreatography procedure in the common bile duct performed on (b)(6) 2019.According to the complainant, during the procedure, when attempted to deploy the advanix biliary stent, the guide catheter was broken and remained in the stent, the physician retrieved the broken guide catheter manually.The procedure was completed with this advanix biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block f10; h6: problem code 1069 captures for the reported event guide catheter broke.Block h10: product investigation analysis: a visual evaluation of the returned advanix rx delivery system revealed that the push catheter was kinked and torn at the proximal section, also the pull wire was kinked at the handle and dislodged of the catheter.Additionally, it was observed that the guide catheter was detached and it was found bent/kink.The stent was not returned for analysis.Based on the product analysis, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance.Patient anatomy and customer maneuvering or handling during the use of the device can lead to kinks to along of the device.Once the push catheter, pull wire and the guide catheter are kinked, this condition can cause resistance due to friction between the components at the moment to retract the pull wire which can lead to issues deploying the stent, continued attempts to deploy the stent or force applied retracting the pull wire in order to release the stent can tear the push catheter and cause the pull wires to get dislodge and the guide catheter detached.Therefore the most probable root cause for this event is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed, no anomalies were observed, the review confirmed that the accepted device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during endoscopic retrograde cholangiopancreatography procedure in the common bile duct performed on (b)(6) 2019.According to the complainant, during the procedure, when attempted to deploy the advanix biliary stent, the guide catheter was broken and remained in the stent, the physician retrieved the broken guide catheter manually.The procedure was completed with this advanix biliary stent.There were no patient complications reported as a result of this event.

• 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: 8730711
• Report Number: 3005099803-2019-03235
• Device Sequence Number: 2572411
• Product Code: FGE
• UDI-Device Identifier: 08714729787419
• UDI-Public: 08714729787419
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2021
• Device Model Number: M00534320
• Device Catalogue Number: 3432
• Device Lot Number: 0023434879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention