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

Model Number	M00534280
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography in the common bile duct performed on (b)(6) 2019.According to the complainant, the lesion was choledocholithiasis in bile duct.During the procedure, after removing the stone, the physician used the advanix biliary stent for drainage.While deploying the stent, the guide catheter broke.The broken inner guide catheter remained within the push catheter, enabling the delivery system to be removed in one piece.The procedure was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: (b)(6).Block f10: problem code 1069 captures the reportable event of guide catheter break.Block h10: product analysis the returned advanix rx bili preload db was analyzed, and a visual evaluation noted the stent was returned unloaded from the delivery system.The pull wire was kinked/bent in several locations.The push catheter was torn adjacent the handle and the pull wire was dislodged from the delivery system, push catheter was also kinked/bent in several locations.The push catheter was cut to expose and inspect the guide catheter and it was observed the guide catheter was detached/separated from the delivery system, also it was kinked/bent in several locations.The reported event was confirmed.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Patient anatomy and customer maneuvering during the use of the device can lead to kink/bend the push catheter, guide catheter and pull wire.Once the push catheter, guide catheter and pull wire are kinked, this condition can cause resistance due to fiction between the components at kinked areas, continued attempts to retract the pull wire/guide catheter can result in guide catheter detachment and force applied to the device to release the stent can tear the push catheter.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography in the common bile duct performed on (b)(6) 2019.According to the complainant, the lesion was choledocholithiasis in bile duct.During the procedure, after removing the stone, the physician used the advanix biliary stent for drainage.While deploying the stent, the guide catheter broke.The broken inner guide catheter remained within the push catheter, enabling the delivery system to be removed in one piece.The procedure was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 9592318
• Report Number: 3005099803-2019-06451
• Device Sequence Number: 458281
• Product Code: FGE
• UDI-Device Identifier: 08714729787372
• UDI-Public: 08714729787372
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 03/12/2020

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: 12/16/2020
• Device Model Number: M00534280
• Device Catalogue Number: 3428
• Device Lot Number: 0023092097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 52