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

Model Number	M00539330
Medical Device Problem Codes	Break (1069); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during a biliary drainage procedure in the bile duct performed on (b)(6) 2022.During the preparation, when the device was unpacked, it was found that the delivery system was not connected to the stent.The procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.Investigation results revealed that the guide catheter was detached/separated, therefore this event has been deemed an mdr reportable event.
Additional Manufacturer Narrative
(b)(4).The returned flexima biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached from the proximal section.The stent remained attached to the delivery system by the suture thread.Additionally, it was observed that the suture hole of the push catheter was torn and the guide catheter at the distal part was observed stretched.The push catheter was kinked at some sections.No other problem with the device was 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; after analysis, it was determined that the delivery system was manipulated, the push catheter was kinked, the guide catheter was detached at the proximal part, the stent remained attached to the delivery system indicating that there was not a premature deployment, instead it seems that there was a failure deployment, the suture hole of the push catheter was torn and the guide catheter was stretched.It is possible that user manipulation during preparation and/or some technique performed with the delivery system caused the push catheter to get kinked.As a consequence of these kinks, the user may have experienced difficulties to remove the guide catheter and this resulted in detaching the proximal part of the guide catheter and stretching part of it.The tough movement experienced during these actions may have caused the tear in the push catheter suture hole.Based on the information available and the analysis performed, it was determined that the overall investigation conclusion code for the complaint 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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 14515605
• Report Number: 3005099803-2022-02756
• Device Sequence Number: 6466318
• Product Code: FGE
• UDI-Device Identifier: 08714729162643
• UDI-Public: 08714729162643
• 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): 05/26/2022

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: 05/19/2024
• Device Model Number: M00539330
• Device Catalogue Number: 3933
• Device Lot Number: 0027352943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 58 KG