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

Model Number	M00539210
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be used in the common bile duct to treat a stenosis during a stent placement procedure performed on (b)(6) 2023.During preparation, when the device was unpacked, it was noticed that the stent barb at the distal end was cracked.The procedure was completed with another flexima biliary stent.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: the initial reporter's phone number: (b)(6).Block h6: imdrf device code a0414 captures the reportable event of stent barb torn material.
Additional Manufacturer Narrative
Block e1: the initial reporter's phone number is (b)(6).Block h6: imdrf device code a0414 captures the reportable event of stent barb torn material.Block h10: a flexima biliary preloaded stent was received for analysis.The stent was still attached to the push catheter.Visual inspection found the stent damaged (melted).The stent barb was deformed.No other problems were noted with the device.Product analysis confirmed the reported event of stent barb torn material.There is not enough evidence to determine whether the reported event of stent barb torn material and the observed event of stent damaged were due to the physician's technique or the manipulation of the device during preparation.The investigation findings do not lead to a clear conclusion about the cause of the reported event, therefore the most probable cause was unable to be established.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be used in the common bile duct to treat a stenosis during a stent placement procedure performed on (b)(6) 2023.During preparation, when the device was unpacked, it was noticed that the stent barb at the distal end was cracked.The procedure was completed with another flexima biliary stent.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: FLEXIMA 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: 18147472
• Report Number: 3005099803-2023-06190
• Device Sequence Number: 7609458
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K965147
• 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): 01/10/2024

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: 11/08/2025
• Device Model Number: M00539210
• Device Catalogue Number: 3921
• Device Lot Number: 0030508062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 70 KG