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

Model Number	M00539270
Medical Device Problem Codes	Positioning Failure (1158); Stretched (1601); Use of Device Problem (1670); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was used to treat biliary stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During the procedure, the stent was unable to deploy.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 at the conclusion of the procedure was reported to be stable.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." additionally, it was also reported that the barb flap cover was not used to insert the device through the biopsy cap.Per ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the physician did not follow the steps cited in the ifu.This event has been deemed an mdr reportable event based on the investigation results which revealed that the stent barb was torn.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block e1: the initial reporter's address is (b)(6).Block h6: imdrf device code a0414 captures the reportable investigation results of stent barb torn.Block h10: a flexima biliary preloaded stent was received for analysis.The stent was received still attached to the push catheter.Visual inspection found the guide catheter pulled to the brown marker and was stretched and kinked.The stent barb was torn and the push catheter was damaged.During functional inspection, the stent was deployed manually by pulling the remaining guide catheter.No other problems were noted with the device.The reported event of stent failure to deploy was confirmed as the stent was received still attached to the push catheter.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.It was reported that the guidewire was inside the patient during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." additionally, it was also reported that the barb flap cover was not used to insert the device through the biopsy cap.Per ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." it is most likely that the barb flap cover not being used to insert the device through the biopsy cap caused the observed event of stent barb torn which resulted in the resistance when trying to deploy the stent during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instruction.

• 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: 18716220
• Report Number: 3005099803-2024-00479
• Device Sequence Number: 5525281
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: 08714729162582
• 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): 02/15/2024

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: 03/13/2025
• Device Model Number: M00539270
• Device Catalogue Number: 3927
• Device Lot Number: 0029037233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 79 KG