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

Model Number	M00534270
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blocks b5 and h6 (device codes) were corrected based on the investigation findings that it was the pull wire that was detached, and not the guide catheter.Block e1: initial reporter facility name is sun yat-sen memorial hospital, sun yat-sen university; reported here as facility name exceeded character limit for designated field.Block h11: upon further review of the investigation, it has been determined that the part detached was the pull wire and not the guide catheter.Therefore, this is no longer considered an mdr reportable event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted in the inferior bile duct to treat jaundice with malignant tumor during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.During preparation, it was noted that the connecting wire in the front end of the stent was broken.The procedure was completed with another advanix biliary stent, there were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name is (b)(6); reported here as facility name exceeded character limit for designated field.Block h6: imdrf device code a0401 captures the reportable investigation findings of guide catheter break.Block h11: an advanix biliary stent with naviflex rx delivery system was returned for analysis; the suture was not returned.Visual examination of the returned device found the guide catheter was detached and kinked.The push catheter was also kinked.The push catheter suture hole and the stent suture hole were torn.After destructive test, it was observed that the detached portion was the pull wire from the guide catheter.No other damages were noted to the stent and delivery system.The reported event of suture break was confirmed.Taking all available information into consideration, the investigation concluded that the reported event and observed damages were likely due to factors encountered during the procedure.It is possible that the tortuosity of the procedure, the technique used by the physician (force applied), limited the performance of the device and contributed to the reported event and observed problems.Therefore, the most probable cause of the reported event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted in the inferior bile duct to treat jaundice with malignant tumor during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.During preparation, it was noted that the connecting wire in the front end of the stent was broken.The procedure was completed with another advanix biliary stent, there were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that the guide catheter was broken.Please see block h11 for the full investigation details.

• 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: 20578297
• Report Number: 3005099803-2024-05513
• Device Sequence Number: 8508395
• Product Code: FGE
• UDI-Device Identifier: 08714729787365
• UDI-Public: 08714729787365
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 05/29/2025
• Device Model Number: M00534270
• Device Catalogue Number: M00534270
• Device Lot Number: 0031713691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 56 KG