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

Model Number	M00534220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical problem code: (b)(4).The returned advanix biliary stent was analyzed, and a visual evaluation noted that the suture hole of the push catheter and stent were torn, the suture thread was detached and didn't return.The push catheter presented some kinks and the guide catheter was kinked.One barb of the stent was damaged.No other problems 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.It was determined that the push catheter and guide catheter were kinked, the suture hole of the push catheter and guide catheter were torn and one barb of the stent was damaged.The kinks on the push catheter may be related to user manipulation, some technique performed during procedure and/or tortuous anatomy could have even contributed on this issue, once the push catheter was kinked the user may have experienced difficulties to pull the pull wire which took the user to apply an excessive force/tension that ended affecting the guide catheter.It's possible that during the deployment the stent got damaged by some friction/tension applied to it causing the damages on the barb, as consequence of these conditions, the suture holes got torn and the stent got a premature deployment.Therefore, based on the analysis performed and all the information gathered from the customer and the problems 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 the 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 in the bile duct performed on (b)(6) 2022.During the procedure, when advancing the stent into the bile duct, it deployed prematurely even though the handle was in the locked position.The procedure was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.Investigation results revealed that the stent damaged, therefore this event has been deemed an mdr reportable 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: 13995619
• Report Number: 3005099803-2022-01500
• Device Sequence Number: 11855276
• Product Code: FGE
• UDI-Device Identifier: 08714729787310
• UDI-Public: 08714729787310
• 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
• 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): 04/04/2022

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: 08/27/2023
• Device Model Number: M00534220
• Device Catalogue Number: 3422
• Device Lot Number: 0027919681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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