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

Model Number	M00534350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) in the bile duct performed on (b)(6) 2022.During preparation, it was noticed that the suture wire that holds the stent to the delivery system was broken.Another advanix biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Investigation results revealed the stent barb was torn, therefore this event has been deemed a reportable event.
Additional Manufacturer Narrative
Medical device problem code a0401 captures the reportable investigation result of stent barb torn.The returned advanix biliary stent was analyzed, and a visual evaluation noted the suture hole of the stent was torn, it was found traces of use.One stent barb was returned torn.The suture thread was not returned, indicating that it was detached.No other problems with the device were noted.The reported event was confirmed.According to the product analysis of the returned device, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.After analysis it was determined that the device had traces of use, which suggests that the device was used.Most likely, during the procedure the physician applied some manipulation/technique that caused the holes of the suture thread to tear and/or even the tortuous anatomy could have contributed to this issue, once the difficulties were present and the user tried to deploy the stent which caused the stent barb to be torn and possibly that the suture thread may have experienced some tension that ended up coming off.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable investigation result of stent barb torn.Block h10: the returned advanix biliary stent was analyzed, and a visual evaluation noted the suture hole of the stent was torn, it was found traces of use.One stent barb was returned torn.The suture thread was not returned, indicating that it was detached.No other problems with the device were noted.The reported event was confirmed.According to the product analysis of the returned device, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.After analysis it was determined that the device had traces of use, which suggests that the device was used.Most likely, during the procedure the physician applied some manipulation/technique that caused the holes of the suture thread to tear and/or even the tortuous anatomy could have contributed to this issue, once the difficulties were present and the user tried to deploy the stent which caused the stent barb to be torn and possibly that the suture thread may have experienced some tension that ended up coming off.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Block h11: block e1 initial reporter title, initial reporter first name and initial reporter last name and block e3 occupation have been corrected.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) in the bile duct performed on (b)(6) 2022.During preparation, it was noticed that the suture wire that holds the stent to the delivery system was broken.Another advanix biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Investigation results revealed the stent barb was torn, therefore this event has been deemed a 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: 16292533
• Report Number: 3005099803-2023-00280
• Device Sequence Number: 15053001
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 03/24/2023

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: 11/17/2023
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0028401357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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