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

Model Number	M00534680
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to february 1, 2022 as no event date was reported.(b)(4).The returned advanix biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached and kinked.The pull wire was fully retracted and it was kinked.The device presented wastes from the procedure.Also, the suture was detached and the suture hole of the stent was torn.A microscope inspection revealed that the suture hole of the push catheter was torn.No other problem with the device were noted.The reported event was confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.After analysis, it was determined that the guide catheter was detached and kinked, the suture was detached, the pull wire was kinked, and it was fully retracted.Additionally, both suture holes were torn.These conditions evidenced that there were problems trough the process of deployment.The guide catheter kinked may be related to some technique applied during the procedure and/or even the anatomical factors met during procedure could have ended kinking it, once the guide catheter kinked, the user might have experienced difficulties to retract the pull wire due the guide catheter provided resistance on the delivery system, as consequence the user may have performed a different technique or applied an extra force that ended kinking the pull wire and it is possible that the tough movement performed may have caused the torn on each suture hole and possibly the detachment of the guide catheter and suture thread.Therefore, based on the analysis performed and all the information gathered from the customer and the issues found the overall investigation conclusion code assigned will be "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
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The procedure date was not reported.There were no patient complications reported as a result of this event.Investigation results revealed that the guide catheter was detached, therefore this event has been deemed an mdr reportable event.See investigation summary for more details.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14674069
• Report Number: 3005099803-2022-03057
• Device Sequence Number: 5617588
• Product Code: FGE
• UDI-Device Identifier: 08714729787235
• UDI-Public: 08714729787235
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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: 12/02/2023
• Device Model Number: M00534680
• Device Catalogue Number: 3468
• Device Lot Number: 0028491260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown