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

Model Number	M00539260
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned flexima biliary stent was analyzed, and a visual evaluation noted that the stent was returned loaded.The guide catheter hub was detached and was not returned for analysis.A bent was found on distal section of guide catheter.The guide catheter remained stretched and detached on the proximal section.No other problems with the device were noted.The reported event was confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.As per complaint information, the issue occurred during procedure.It is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.User technique when the device was removed from its packaging or advancing the device through the scope can cause the kink on the catheter, this condition can cause friction between the components at kinked or bent area in the catheter.After the product analysis, it was found the guide catheter hub was detached and guide catheter was stretched.Based on the guide catheter stretched, it means that the guide catheter detached could happen because of using excess force or due to physician technique when pulling the guide catheter.Therefore, it was determined that the overall investigation conclusion code for the encountered issues will be documented as adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde biliary drainage (erbd) procedure in the common bile duct performed on (b)(6) 2022.A patient who suffered from common bile duct dilatation combined with stones had a large number of stones were removed and re-angiography showed no obvious residual stones.During the procedure, when the device was placed for drainage, the stent was unable to be deployed.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.Investigation results revealed that the guide catheter was detached/separated, therefore this event has been deemed an mdr reportable event.

• 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: 16010070
• Report Number: 3005099803-2022-07211
• Device Sequence Number: 20211502
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2022

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: 01/17/2025
• Device Model Number: M00539260
• Device Catalogue Number: 3926
• Device Lot Number: 0028697361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 12/19/2022
• Date Device Manufactured: 01/18/2022
• 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: Male
• Patient Weight: 55 KG