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

Model Number	M00532190
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.However, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, the stent could not be deployed.The stent and the delivery device damaged.The stent and the delivery system were removed from the patient.The procedure was successfully completed with another advanix naviflex biliary stent.There were no patient complications reported.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.
Event or Problem Description
It was reported to boston scientific corporation that an advanix naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, the stent could not be deployed.The stent and the delivery device damaged.The stent and the delivery system were removed from the patient.The procedure was successfully completed with another advanix naviflex biliary stent.There were no patient complications reported.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 h6: device code 2588 captures the reportable event of stent damaged.Block h10: the returned advanix biliary stent was analyzed, and a visual evaluation noted that the stent was bent/kinked in several locations at proximal pigtail.The kinks observed on the stent could have caused issues to deploy it.No other issues with the device were noted.The reported event was confirmed.Based on the product analysis, it was determined that the proximal pigtail was kinked and this could have caused issues to deploy the stent properly.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Device under tortuous condition due to patient anatomy or customer use/manipulation/maneuvering could have kinked the stent at proximal section, this condition would have result in issues to deploy the stent during the procedure.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 manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 10474542
• Report Number: 3005099803-2020-03619
• Device Sequence Number: 2939589
• Product Code: FGE
• UDI-Device Identifier: 08714729786986
• UDI-Public: 08714729786986
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101786
• 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): 10/13/2020

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: 05/07/2021
• Device Model Number: M00532190
• Device Catalogue Number: 3219
• Device Lot Number: 0023758892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 53