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

Model Number	M00539220
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
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 attached to the push catheter by the suture thread.The guide catheter was found stretched, kinked and detached at the proximal section.The stent was kinked.Additionally it was observed the push catheter with some kinks.Media inspection showed the guide catheter slightly kinked.No other issues with the device were noted.The reported event was confirmed.According to product analysis, it was determined that the device returned with the guide catheter kinked, stretched and detached close to the proximal section, the stent was observed kinked, and the push catheter had some kinks.These conditions indicate a stent failure to deploy.The push catheter kinked may be related to user manipulation and/or some technique applied during procedure; once the push catheter was kinked the user may have experienced difficulties to pull the guide catheter, this took the user to apply an extra force/technique that ended up stretching, kinking it and finally detaching it, while the user tried to pull out the guide catheter through these conditions the stent may have been affected by the tough movement and this caused the observed kink on it.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.
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 bile duct, performed on (b)(6) 2021.During the procedure, the stent failed to deploy.Another flexima biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the guide catheter was slightly kinked.This event has been deemed a reportable event based on the investigation finding of guide catheter detached/separated.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12713004
• Report Number: 3005099803-2021-05543
• Device Sequence Number: 4703827
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: 08714729162537
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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: 11/23/2023
• Device Model Number: M00539220
• Device Catalogue Number: 3922
• Device Lot Number: 0026411163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1