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

Model Number	M00539260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: initial reporter's city: (b)(6); reported here as it exceeded the character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of inner guide catheter detached.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be used to treat a choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.During the procedure, while pulling the inner guide catheter to deploy the stent, the inner guide catheter tore.There was no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block b5 has been updated with the additional information received on october 29, 2024.Block e1: initial reporter's city: (b)(6); reported here as it exceeded the character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of inner guide catheter detached.Block h11: the flexima biliary preloaded stent was received for analysis.Visual inspection was performed and revealed the following: the guide catheter was kinked and detached, the push catheter was kinked, the push catheter's suture hole was torn, and the suture was detached.No other damages were noted on the device.Product analysis confirmed the reported event of the catheter guide break.The investigation concluded that the reported event and additional observed damages were most likely due to procedural factors encountered during the procedure.Factors such as the tortuosity of the procedure, the technique used by the physician, the amount of force applied to the device, and the manner in which the device was manipulated that may have contributed to the separation and kinking of the guide catheter, the kinking of the push catheter, the tearing of the push catheter's suture hole, and the separation of the suture.Therefore, a review and analysis of all available information indicated that the most probable cause is an adverse event related to the procedure.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be used to treat a choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.During the procedure, while pulling the inner guide catheter to deploy the stent, the inner guide catheter tore.There was no patient complication reported as a result of this event.Additional information received on october 29, 2024.It was reported that the flexima biliary preloaded stent was to be used in the common bile duct.

• 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: 20428012
• Report Number: 3005099803-2024-04888
• Device Sequence Number: 18107950
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: 08714729162575
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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 Model Number: M00539260
• Device Catalogue Number: 3926
• Device Lot Number: 0032682756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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 Sex: Unknown