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

Model Number	M00534230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: approximately (b)(6) per account.(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
This report pertains to the first of two devices that were used in the same procedure.It was reported to boston scientific corporation that the previously implanted advanix naviflex biliary stent was removed during an endoscopic retrograde cholangiopancreatography (ercp) in the common bile duct performed on (b)(6) 2020.On (b)(6) 2020, two advanix naviflex biliary stents were implanted successfully.According to the complainant, during the planned stent removal, when the physician attempted to pull the stent with the use of snare through the ercp scope, it broke the stent into two pieces.The same happened to the second stent.Reportedly, the physician chose to leave the broken piece in the patient.The procedure was successfully completed with another advanix naviflex 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 fine.
Additional Manufacturer Narrative
Block a4: patient weight: approximately 180-190lbs.Block h6: device code 1069 captures the reportable event of stent broken.Block h10: the returned advanix biliary stent was analyzed, and a visual evaluation noted that the stent was blackened at broken section, also it was bent and broken at proximal section.The delivery system was not returned.No other issues with the device were noted.The reported event was confirmed.Based on the provided and collected information, this issue occurred during the procedure, while stent was being removed and it was implanted for some days.It indicates that the device was received and implanted in good conditions, however procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.The stent was grabbed with a snare.Using a snare or forceps is a standard biliary stent removal technique.The damages found on the stent (bent/broken) are typically made due to grabbing and pulling the stent with a snare or forceps during the stent removal.Once the stent is caught with the snare or forceps, continued attempts to remove it can damage the stent and force to remove it can result in stent breakage.Also the stent was blackened due to it was implanted for some days.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.
Event or Problem Description
Note: this report pertains to the first of two devices that were used in the same procedure.It was reported to boston scientific corporation that the previously implanted advanix naviflex biliary stent was removed during an endoscopic retrograde cholangiopancreatography (ercp) in the common bile duct performed on (b)(6) 2020.On (b)(6) 2020, two advanix naviflex biliary stents were implanted successfully.According to the complainant, during the planned stent removal, when the physician attempted to pull the stent with the use of snare through the ercp scope, it broke the stent into two pieces.The same happened to the second stent.Reportedly, the physician chose to leave the broken piece in the patient.The procedure was successfully completed with another advanix naviflex 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 fine.

• 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: 10468683
• Report Number: 3005099803-2020-03625
• Device Sequence Number: 14125151
• Product Code: FGE
• UDI-Device Identifier: 08714729787327
• UDI-Public: 08714729787327
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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: 09/17/2021
• Device Model Number: M00534230
• Device Catalogue Number: 3423
• Device Lot Number: 0024453887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR