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

Model Number	M00534280
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter's healthcare facility is (b)(6) hospital; reported here as it exceeded the character limit.Block h6: imdrf device code a0401 captures the reportable investigation result of guide catheter detached.Block h11: an advanix rx biliary preloaded stent was received for analysis.Visual inspection revealed that the guide catheter and the suture were detached.The stent's suture hole and the push catheter's suture hole were torn.No other damage was noted on the device.Product analysis confirmed the reported event of suture detachment.Although it was reported that the event occurred during preparation while unpacking, the condition of the returned device indicates that it was used during the procedure.Considering all available information, the investigation concluded that the observed damage was most likely due to procedural factors encountered during insertion of the device into the scope and attempted deployment.These factors may include the physician's technique, the tortuosity of the procedure, the amount of force applied to deploy the stent, and the pressure on the suture.Therefore, a review and analysis of all available information indicate that the most probable cause is an adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preloaded stent was to be implanted in the inferior bile duct to treat a malignant tumor, as indicated by jaundice, during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During preparation, after unpacking, the connection wire of the bile duct stent tip became disconnected.The procedure was completed with another device of the same type.No patient complications were reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: this complaint has been deemed mdr reportable based on the investigation result which revealed the guide catheter was detached.

• 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: 20533007
• Report Number: 3005099803-2024-05385
• Device Sequence Number: 18223908
• Product Code: FGE
• UDI-Device Identifier: 08714729787372
• UDI-Public: 08714729787372
• 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
• Report Date (Section B): 10/25/2024

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: 11/05/2025
• Device Model Number: M00534280
• Device Catalogue Number: 3428
• Device Lot Number: 0032797000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 52 KG