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

Model Number	M00539250
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be used during a bile duct stenting procedure in the bile duct performed on (b)(6) 2022.During unpacking, it was found that the suture was twisted.The procedure was completed but it was unknown what completed the procedure.A photo of the complaint was provided and showed that the suture was twisted and the push catheter was kinked.There were no patient complications reported as a result of this event.Investigation results revealed the guide catheter was detached/separated, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Medical device problem code captures the reportable investigation result of guide catheter detached/separated.The returned flexima biliary stent was analyzed, and a visual evaluation noted that the suture was twisted.The push catheter and guide catheter were kinked and the guide catheter was detached.Additionally, the guide catheter exit through a barb.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, the guide catheter and push catheter were kinked and the guide catheter was detached and the suture was twisted in the media analysis.It is most likely that user manipulation along the preparation and/or some technique performed to the delivery system caused the kink in the push catheter, once the push catheter was kinked the user may have experienced difficulties to remove the guide catheter, as consequence the user may have applied a different technique that ended kinking and detaching the guide catheter as well.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.

• 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: 15407675
• Report Number: 3005099803-2022-05020
• Device Sequence Number: 15163448
• Product Code: FGE
• UDI-Device Identifier: 08714729162568
• UDI-Public: 08714729162568
• 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): 09/12/2022

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: 12/02/2023
• Device Model Number: M00539250
• Device Catalogue Number: 3925
• Device Lot Number: 0026452091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2020
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 65 KG