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

Model Number	M00539260
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter's facility name is (b)(6) university; reported here as facility name exceeded character limit for designated field.Block h6: imdrf device code a0414 captures the reportable investigation finding of stent barb torn.Block h11: a flexima biliary stent with delivery system was received for analysis; the stent was not returned.Visual and microscope examination of the returned device found the guide catheter was kinked and accordioned, the push catheter suture hole was torn, the stent barb was torn and deformed.No other problems were noted with the stent and delivery system product analysis confirmed the reported events of stent failure to deploy, catheter - guide kinked and device use of device issue - user error.Taking all available information into consideration, the investigation concluded that it is likely due to factors encountered during the procedure such as the physician's technique, and the force applied when trying to deploy the stent, which limited the performance of the device and contributed to the reported events and observed problems.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the guidewire was in the delivery system during the attempted deployment as the instructions for use (ifu) states, "warning if the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." the physician did not follow the steps cited in the instruction for use (ifu); therefore, a review and analysis of all available information indicated that the most probable cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the common bile duct to treat a biliary stone stenosis during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.During the procedure, the stent was stuck and could not be deployed.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: it was reported that the guidewire was in the delivery system during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "warning if the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that the stent barb was torn.Please see block h11 for the full investigation details.

• 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: 20682486
• Report Number: 3005099803-2024-05772
• Device Sequence Number: 12570110
• 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): 11/14/2024

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: 0033487289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 63 KG