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

Model Number	M00534590
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during a procedure in the bile duct.The event date was not reported.During the procedure, it was noted that when placing the stent in the bile duct, it failed to deploy.Also, a resistance was observed when trying to insert the stent into the guidewire.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the returned advanix biliary stent was analyzed, and a visual evaluation noted that the pull wire was retracted without any issue or tension.The device was disassembled to confirm the guide catheter that was detached from the pull wire.The activation of the device was performed, pull wire was retracted but stent did not deploy.No other problem with the device were noted.The reported event was confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.After the visual inspection of the device, a bent was identified on proximal section of the push catheter and distal stent barb deformed.As per complaint information, the issue occurred during procedure.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.User technique when advancing the device through the scope can cause the deformation on the barb and the push catheter kink.During the functional inspection, when the pull wire was retracted, the stent did not deploy.It was observed that the guide catheter does not retract with the pull wire.Based on this, it was decided to disassembly the device and it was found that the guide catheter was detached from the pull wire.The detached may happen due the excess of force used by the physician pulling the pull wire, also the bent on the push catheter and torsion by anatomical factors can cause tension on the pull wire and could influence on the detachment.Therefore, based on the information available and the analysis performed, the overall conclusion code for the complaint will be as adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.

• 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: 16010342
• Report Number: 3005099803-2022-07215
• Device Sequence Number: 12404648
• Product Code: FGE
• UDI-Device Identifier: 08714729787143
• UDI-Public: 08714729787143
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/19/2022

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: 10/11/2023
• Device Model Number: M00534590
• Device Catalogue Number: 3459
• Device Lot Number: 0028182048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 12/19/2022
• Date Device Manufactured: 10/11/2021
• 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