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

Model Number	M00539230
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned flexima biliary preloaded was analyzed, and a visual evaluation noted that the guide catheter was stretched, kinked and detached.The push catheter was kinked and buckled.The stent and suture thread was not returned.No other issues with the device were noted.The reported event was confirmed.According to product analysis, it is most likely that user manipulation while setting up the device through the endoscope, some technique applied during procedure and/or even tortuous anatomy could have contributed on the kinks along the push catheter, the push catheter kinked provided resistance to remove the guide catheter, as consequence of this condition the user may have attempted to pull out the guide catheter with a great amount of force/tension which ended kinking it and stretching it, during the procedure all these conditions finally leaded the detachment of the guide catheter and the buckle of the push catheter, in summary the delivery system experiences difficulties to deploy the stent based on all the problems found.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) /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 stent placement procedure in the right hepaticus, performed on (b)(6) 2021.During the procedure, the nurse inserted the stent into the working channel of the duodenoscope.The outer orange sleeve was placed to hold the stentbarb down for insertion.The flexima with delivery system was advanced through the scope channel using short strokes until the flexima was in the right position.The tuohy-borst adapter was loosened and the catheter and the guidewire were pulled back to deliver the flexima but there was resistance and the guide catheter coiled and the stent failed to deploy.Another stent of a different model was opened and successfully completed the procedure.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of guide catheter broken.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable investigation result of guide catheter break.Block h10: the returned flexima biliary preloaded was analyzed, and a visual evaluation noted that the guide catheter was stretched, kinked and detached.The push catheter was kinked and buckled.The stent and suture thread was not returned.No other issues with the device were noted.The reported event was confirmed.According to product analysis, it is most likely that user manipulation while setting up the device through the endoscope, some technique applied during procedure and/or even tortuous anatomy could have contributed on the kinks along the push catheter, the push catheter kinked provided resistance to remove the guide catheter, as consequence of this condition the user may have attempted to pull out the guide catheter with a great amount of force/tension which ended kinking it and stretching it, during the procedure all these conditions finally leaded the detachment of the guide catheter and the buckle of the push catheter, in summary the delivery system experiences difficulties to deploy the stent based on all the problems found.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: correction updated b5.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography stent placement procedure in the right hepaticus, performed on (b)(6), 2021.During the procedure, the nurse inserted the stent into the working channel of the doudenscope.The outer orange sleeve was placed to hold the stentbarb down for insertion.The flexima with delivery system was advanced through the scope channel using short strokes until the flexima was in the right position.The tuohy-borst adapter was loosened and the catheter and the guidewire were pulled back to deliver the flexima but there was resistance and the guide catheter coiled and the stent failed to deploy.A different manufacturer's stent was opened and used to successfully complete the procedure.There was no serious injury, nor were there any adverse patient effects 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: 13172887
• Report Number: 3005099803-2021-08018
• Device Sequence Number: 14618770
• 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,Followup
• Report Date (Section B): 02/09/2022

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: 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: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/09/2022
• 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