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

Model Number M00539260

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific that a flexima biliary stent was used during a procedure.The procedure date is unknown.During the procedure, when the physician attempted to deploy the stent, great resistance was felt.The physician removed the device from the duodenoscope, reassembled, and after a few attempts experiencing continued resistance due to the inability to remove the guidewire, the physician deployed the stent and completed the procedure.The 0.025 thread guidewire (non-boston scientific, manufacturer is unknown) used during the procedure was removed from the scope, however, could not be removed from the delivery catheter after the procedure.There were no known patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.This event has been deemed a reportable event based on the investigation finding of guide catheter detached.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.Imdrf device code (b)(4) captures the reportable event of guide catheter detached/separated.The returned flexima biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached from the delivery system and accordioned over the guidewire.Additionally, the stent was deployed from the delivery system.Based on the device analysis, the reported event of stent failed to deploy could not be confirmed since the complete delivery system was not returned.However, the reported event of guidewire stuck was confirmed.No other problems with the device were noted.Based on all the gathered information, the evidence suggests that the physician faced some adversities while introducing and/or removing the guidewire.This failure could have been caused by the technique used or the patient anatomy, therefore, the most probable root cause is adverse event related to the procedure.

• Brand Name: FLEXIMA BILIARY
• Type of Device: 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: 16620498
• MDR Text Key: 312406642
• Report Number: 3005099803-2023-01505
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: 08714729162575
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K965147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2023

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
• Device Operator: Health Professional
• Device Model Number: M00539260
• Device Catalogue Number: 3926
• Device Lot Number: 0028918152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1