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

Model Number	M00534230
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).(b)(4).The returned advanix biliary stent was analyzed, and a visual evaluation noted that the push catheter and pull wire were kinked.Functional & microscope inspection revealed that the device went trough difficulties to deploy the stent.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, after analysis it was determined that the push catheter and pull wire were kinked, it was observed the stent kinked and one barb was torn, during functional inspection the pull wire presented difficulties to be retracted/extended due the kinks.Microscope inspection revealed that the suture holes of the stent and push catheter were torn.The difficulties presented when actuating the pull wire indicates that the process of deployment could be affected, this difficulties are related to the kinks on the push catheter that took the user to apply an extra force or technique in order to deploy the stent, as consequence of these conditions the pull wire got kinked and the suture holes torn, part of the consequences of this technique while the difficulties were present were the issues observed on the stent.Through the process of deployment the stent may have been submitted to some tension that ended kinking it and tearing part of one barb.Review and analysis of all available information indicated that the root cause of the problems found 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
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) 2021.A (b)(6) years old male patient, had choledocholithiasis and high jaundice, went to a procedure and the multiple stones were removed by basket.During the procedure, after the stent was placed in the anatomy, they found that the stent could not be deployed.The procedure was successfully completed with another advanix 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 stable.Note: the device expired on may 1, 2021, but the device was used during a procedure on (b)(6) 2021.Investigation results revealed that the stent was torn, 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
• MDR Report Key: 12657631
• Report Number: 3005099803-2021-05213
• Device Sequence Number: 1220202
• Product Code: FGE
• UDI-Device Identifier: 08714729787327
• UDI-Public: 08714729787327
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: Other
• Device Expiration Date: 05/01/2021
• Device Model Number: M00534230
• Device Catalogue Number: 3423
• Device Lot Number: 0023734160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR