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

Model Number	M00534210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and 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 rx biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure, on an unknown date.On (b)(6) 2022, a planned stent removal procedure was performed.When the physician attempted to remove the stent, a piece of the stent broke off.The procedure was completed and it was unknown if a new stent has been implanted.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure, on an unknown date.On (b)(6), 2022, a planned stent removal procedure was performed.When the physician attempted to remove the stent, a piece of the stent broke off.The procedure was completed and it was unknown if a new stent has been implanted.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a0401 captures the reportable event of stent break.Block h10: the returned advanix rx biliary stent was analyzed, and a visual evaluation noted that, it was detached, kinked, and stretched at the detached section.The delivery system was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, it is most likely that during the removal procedure the technique applied and/or some anatomical factors contributed on kinking the stent and it is possible that the kink caused resistance while removing it, as consequence the customer may have applied a different technique or tension to remove the stent and this could have caused the stretch and detachment of the stent.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.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
• 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: 14515821
• Report Number: 3005099803-2022-02822
• Device Sequence Number: 15112088
• Product Code: FGE
• UDI-Device Identifier: 08714729787303
• UDI-Public: 08714729787303
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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 Model Number: M00534210
• Device Catalogue Number: 3421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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