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

Model Number	M00539220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was noted that implantation of a flexima biliary stent was needed due to the tumor.They followed the instructions and were able to position the flexima biliary stent in the channel; however when a release was performed, they could not release it successfully.It was found that the flexima biliary stent became broken due to how much effort had been exerted.The procedure was successfully completed with another flexima biliary 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.
Additional Manufacturer Narrative
Block h6: medical device code a0401 captures the reportable event of stent broken.Block h10: the returned flexima biliary stent was analyzed, and a visual evaluation noted that the stent was not returned and it is not possible to confirm if it was break.Additionally, the push catheter was returned kinked in several locations, the push catheter suture hole was torn and the guide catheter did not return indicating that it was detached.A microscope inspection was performed and found that the push catheter suture hole was torn.No other problem with the device were noted.The reported event was not confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.During the analysis it was observed that the stent was not returned.Due to lack of evidence and without proper evaluation of the stent, it is not possible to determine if the stent broke due to procedural factors or was related to a device malfunction.Therefore, cause not established is assigned as the cause code for stent break since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Additionally, it was observed that the push catheter was returned kinked, the push catheter suture hole was torn and the guide catheter did not return indicating that it was detached.It is possible that anatomical or procedural factors encountered during procedure could lead to the reported issues.Due to the condition of the device, it is possible that these failures could have difficulty in the procedure.Therefore, the events of guide catheter detached, push catheter kinked and push catheter suture hole torn will be documented as not reported allegation with a cause code of adverse event related to procedure due to the adverse event occurred during the procedure and the device had no influence on the event.Therefore, it was determined that the overall investigation conclusion code for the encountered issues will be documented as "adverse event related to procedure" since he adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was noted that implantation of a flexima biliary stent was needed due to the tumor.They followed the instructions and were able to position the flexima biliary stent in the channel; however when a release was performed, they could not release it successfully.It was found that the flexima biliary stent became broken due to how much effort had been exerted.The procedure was successfully completed with another flexima biliary 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.

• 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: 13592645
• Report Number: 3005099803-2022-00665
• Device Sequence Number: 11727461
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: 08714729162537
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 09/12/2022

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: 11/23/2023
• Device Model Number: M00539220
• Device Catalogue Number: 3922
• Device Lot Number: 0026411163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 65 KG