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); Deformation Due to Compressive Stress (2889); Device-Device Incompatibility (2919); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned flexima biliary preloaded was analyzed, and a visual evaluation noted that the guidewire was stuck in the guide catheter.The guide catheter was stretched and it was detached.Push catheter suture hole was torn.It was also found that the push catheter was buckled.No other issues with the device were noted.The reported event was confirmed.According to product analysis, it is most likely that the during the procedure the user tried to removed the guidewire and felt some resistance or difficulty which took the user to apply an extra force, this ended stretching the guide catheter and during the attempt of deploying the stent the guide catheter could not be pulled correctly due the conditions, this ended detaching one part of it and the force applied during the procedure may have leaded the buckle of the push catheter and the tear of the suture hole.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the left hepaticus, performed on (b)(6) 2021.During the procedure and inside the patient, when the nurse inserted the tapered tip into the working channel of the duodenoscope and the outer orange sleeve was placed to hold the stentbarb down for insertion.The flexima delivery system was advanced through the scope channel using short strokes until the flexima was in the right position.The tuohy-borst adapter was loosen and the catheter and the guidewire were pulled back to deliver the flexima.The guide catheter occured like a coil and the stent failed to deploy.Another stent of a different model was opened and successfully completed the procdure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of guide catheter broken.

• 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: 12900806
• Report Number: 3005099803-2021-06113
• Device Sequence Number: 3900550
• Product Code: FGE
• UDI-Device Identifier: 08714729162544
• UDI-Public: 08714729162544
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/30/2021

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: 07/18/2024
• Device Model Number: M00539230
• Device Catalogue Number: 3923
• Device Lot Number: 0027688926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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: Unknown