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

Model Number	M00539210
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that an flexima biliary stent was attempted to be placed in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The procedure date is unknown.During the procedure, it was found to be difficult to access the desired stent location due to a significant stricture.Once the physician accessed the desired location, the stent would not deploy.The internal shaft was stuck with the outside shaft and there was friction during attempted deployment.When the physician applied additional force to deploy the stent, the delivery system and stent came out of the duodenoscope.The procedure was prolonged and the physician used an alternative method to ensure drainage and successfully complete the procedure.There were no patient complications reported as a result of this event.The patient outcome is expected to fully recover.This event has been deemed a reportable event based on the investigation finding of guide catheter detached.
Additional 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 captures the reportable investigation findings of guide catheter detached separated.The returned flexima biliary stent was analyzed, and a visual evaluation noted that the delivery system was returned with the guidewire used.The guide catheter was out of the push catheter.The guidewire was stuck inside the guide catheter and the guide catheter was detached.The push catheter was buckled and bent and the suture hole was torn.The stent was measured to verify its dimension.No other problems with the device were noted.The reported event was confirmed.Based on all the gathered information, most likely, user manipulation during the procedure and/or anatomical factors and technique performed have contributed to the push catheter to kink in different sections.Once these kinks were present, the user may have felt resistance while trying to deploy the stent and may have experienced difficulties while retracting the guide catheter, which led the user to apply additional force/tension, and as a consequence, the guide catheter and the suture hole of the push catheter were torn.The guide catheter was detached and accordion by applying additional force.Therefore, the most probable root cause is adverse event related to the procedure.This event was reported by the sales representative.The health care facility is: caja costarricense de seguro social, 300 metros sur de la esquina, cartago, costa rica, 30101, +1(506)25918767, clcoto@ccss.Sa.Cr.

• 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: 16538501
• Report Number: 3005099803-2023-01168
• Device Sequence Number: 6265010
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: M00539210
• Device Catalogue Number: 3921
• Device Lot Number: 0024474522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2019
• 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 Sex: Unknown