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

Model Number	M00539260
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Stretched (1601); Use of Device Problem (1670); Defective Device (2588); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2024
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 implanted in the common bile duct to treat stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent could not be deployed as the black wire between the outer sheath and the stent was not fractured.The procedure was completed with another flexima biliary preloaded stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the guide catheter was detached from the delivery system.
Additional Manufacturer Narrative
Block e1: the initial reporter's address is (b)(6).The initial reporter's phone number is (b)(6).Block h6: imdrf device code a0401 captures the reportable investigation results of guide catheter detached.Block h10: a flexima biliary preloaded stent was received for analysis.Visual inspection found the guide catheter received with a guidewire being stuck.The guide catheter was also found detached from the delivery system, kinked, accordioned/buckled, and stretched.Additionally, the stent was received still attached to the push catheter.The push catheter was bent/kinked.Lastly, the suture hole of the push catheter was torn with evidence of mechanical cut.No other problems were noted with the device.Product analysis confirmed the reported event of stent failure to deploy; however, the reported event of suture deployment issue was not confirmed.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.The complainant reported that the guidewire was inside the patient during the attempted deployment.The ifu states, "if the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." it is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) resulted in the observed events of guide catheter detached, guidewire stuck, kinked, accordioned/buckled, and stretched as well as the push catheter bent/kinked and push catheter hole torn with evidence of mechanical cut which then contributed to the stent being unable to deploy during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

• 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: 19093698
• Report Number: 3005099803-2024-01559
• Device Sequence Number: 20767784
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: 08714729162575
• 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
• Report Date (Section B): 04/11/2024

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: 08/28/2026
• Device Model Number: M00539260
• Device Catalogue Number: 3926
• Device Lot Number: 0032319230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 70 KG