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

Model Number	M00534690
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
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 hemostasis procedure performed on (b)(6) 2022.During the procedure, it was noted that the handle could not break the stone.The procedure was successfully completed with another advanix biliary stent.There were no patient complications reported as a result of this event.The reported problem of handle could not break the stone does not match the intended use of the complaint device; therefore the exact complaint event is unknown.No further information has been obtained despite good faith efforts.Investigation results revealed that the stent was damaged, therefore this event has been deemed an mdr reportable event.
Additional Manufacturer Narrative
(b)(4).The returned advanix rx biliary preload stent was analyzed, and a visual evaluation noted that the push catheter and guide catheter did not present issues.The stent remained attached to the delivery system by the suture thread.The stent was observed damaged close to the proximal barb, and this could be what the customer reported.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 stent was damaged close to the proximal barb and this issue seems caused by tension, the push catheter and guide catheter did not present issues and during functional inspection the pull wire could be retracted and extended without issues.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.

• 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: 14830256
• Report Number: 3005099803-2022-03396
• Device Sequence Number: 19428659
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: 08714729787242
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Physician
• Type of Report: Initial
• 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 Expiration Date: 11/08/2023
• Device Model Number: M00534690
• Device Catalogue Number: 3469
• Device Lot Number: 0028348585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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