MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ADVANIX¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00534290
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 advanix¿ biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2017.According to the complainant, during the procedure, it was noticed that the advanix¿ biliary stent was broken.The procedure was completed with another with the same device.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
A visual evaluation found that the guide catheter was bent and flattened approximately at 17.5cm from the distal end of the guide catheter.The push catheter was kinked and flattened approximately at 81cm from the distal end of the push catheter.The proximal section of the stent was slightly bent where the barb is located also it is deformed in several locations.The suture holes in the stent and push catheter were torn.A functional evaluation for stent deployment was performed and severe resistance was felt due to the damages found on the stent and delivery system.Based on the product analysis, most likely some operational/anatomical factors were encountered during the procedure which may have limited the overall performance of the device.A device under tortuous conditions due to patient anatomy or customer use/manipulation/maneuvering can cause the device to bend/coil leading to kinks and bends in catheters.Bound by kinks and bends, the device would become difficult to retract the pull wire and consequently difficulty to deploy the stent, continued attempts to deploy the stent can result in deforming the stent and tearing the suture holes due to excessive manipulation of the device.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that advanix¿ biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(4) 2017.According to the complainant, during the procedure, it was noticed that the advanix¿ biliary stent was broken.The procedure was completed with another with the same device.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 - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6687415
• Report Number: 3005099803-2017-01956
• Device Sequence Number: 985147
• Product Code: FGE
• UDI-Device Identifier: 08714729787389
• UDI-Public: (01)08714729787389(17)20180831(10)0019572355
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 06/16/2017

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: 08/31/2018
• Device Model Number: M00534290
• Device Catalogue Number: 3429
• Device Lot Number: 0019572355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 90