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

Model Number	M00539230
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Stretched (1601); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
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 retrograde cholangiopancreatography procedure in the bile duct performed on (b)(6) 2021.During procedure, it was noted that when release was performed, the flexima biliary stent did not separate from the guide catheter.It was found that the guide catheter became stretched.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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Investigation results revealed that the guide catheter detached, therefore this event has been deemed an mdr reportable event.
Additional Manufacturer Narrative
Medical problem code: (b)(4).The returned flexima biliary stent was analyzed, and a visual evaluation noted that the stent returned deployed.The guide catheter was kinked at the end and it was detached at the proximal section, the detached part of the guide catheter was stretched and the suture thread didn't return and the suture hole of the push catheter was torn.No other problems with the device were noted.The reported event was 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 push catheter was kinked, the guide catheter was stretched, kinked and detached.The suture hole of the push catheter was torn and the suture thread didn't return indicating that there was problems through the process of deployment.It is most likely that during the procedure user manipulation or some tension caused either by the physician's technique and or even by tortuous anatomy or tight stricture caused the kinks on the push catheter, once the push catheter was kinked the user may have experimented difficulties while pulling out the guide catheter which took the user to apply an extra force that ended stretching and kinking the guide catheter, finally this extra force could have detached the guide catheter and as consequence of the tough movement the suture hole got torn.Therefore, based on the analysis performed and all the information gathered from the customer and the issues found the overall conclusion code assigned will be "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: 13651588
• Report Number: 3005099803-2022-00777
• Device Sequence Number: 5801444
• Product Code: FGE
• UDI-Device Identifier: 08714729162544
• UDI-Public: 08714729162544
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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: 02/19/2024
• Device Model Number: M00539230
• Device Catalogue Number: 3923
• Device Lot Number: 0026841525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• 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 Sex: Male