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

Model Number	M00539260
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter healthcare facility name: (b)(6).Block h6: imdrf device code a0401 captures the reportable investigation result of catheter-guide break.Block h11: a flexima biliary preloaded stent was received for analysis.Visual inspection was performed and found the guide catheter detached and the push catheter suture hole torn.No other damages were noted to the device.Product analysis confirmed the reported event of stent failure to deploy.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The ifu cited: "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion.", however, it was reported that the barb flap cover was not used to insert the device through the biopsy cap.The investigation concluded that the reported event and the observed damages were most likely due to the amount of force or pressure applied to the device as the ifu were not followed.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was used in the bile duct to treat bile duct stones during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.During the procedure, the gray inner sheath could not be pulled out and the stent could not be deployed.The procedure was completed with another flexima biliary stent.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." this complaint has been deemed mdr reportable based on the investigation result which revealed the catheter guide was detached.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: 20191735
• Report Number: 3005099803-2024-04379
• Device Sequence Number: 17840792
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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 Model Number: M00539260
• Device Catalogue Number: 3926
• Device Lot Number: 0032792013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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: 39 YR
• Patient Sex: Male
• Patient Weight: 65 KG