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

Model Number	M00539220
Medical Device Problem Codes	Positioning Failure (1158); Stretched (1601); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr report # 3005099803-2022-07557).It was reported to boston scientific corporation that a flexima biliary stent and a jagwire was used during an endoscopic retrograde cholangiopancreatography (erc), biopsy, and plastic biliary stent placement procedure in the biliary, performed on (b)(6) 2022.During the procedure, upon deployment of the stent, when the guide catheter was pulled, the stent would not detach from the guide catheter and failed to deploy.It was noticed that the distal part of the guide catheter started to elongate and had to be cut with a wire cutter.The jagwire guidewire was also stuck.The procedure was not completed due to this event.It was reported that the patient was transferred to a different facility, incan (national cancer institute, and it was unknown if there was an intervention nor if there was a plan for reschedule to complete 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 stretched and kinked.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned flexima biliary stent was analyzed, and a visual evaluation noted that a bent was found on push catheter and the suture hole was torn.The suture, guide catheter and threaded connector were not returned for analysis.A photo provided by the complaint reporter showed that the guide catheter was stretched and kinked.No other problems with the device were noted.The reported event was confirmed.Based on all the gathered information, most likely, user manipulation during preparation and/or technique performed to the delivery system caused the push catheter to kink.The user may have then experienced difficulty when retracting the guide catheter and deployment of the stent.This may have led the user to apply additional force/tension and as a consequence, the suture hole tore.Therefore, the most probable root cause is adverse event related to the procedure.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr report # 3005099803-2022-07652 and mfr.Report # 3005099803-2022-07557).It was reported to boston scientific corporation that a flexima biliary stent and a jagwire was used during an endoscopic retrograde cholangiopancreatography (erc), biopsy, and plastic biliary stent placement procedure in the biliary, performed on (b)(6) 2022.During the procedure, upon deployment of the stent, when the guide catheter was pulled, the stent would not detach from the guide catheter and failed to deploy.It was noticed that the distal part of the guide catheter started to elongate and had to be cut with a wire cutter.The jagwire guidewire was also stuck.The procedure was not completed due to this event.It was reported that the patient was transferred to a different facility, incan (national cancer institute, and it was unknown if there was an intervention nor if there was a plan for reschedule to complete 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 stretched and kinked.

• 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: 16044131
• Report Number: 3005099803-2022-07652
• Device Sequence Number: 5307094
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: 08714729162537
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 03/03/2023

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: 05/25/2025
• Device Model Number: M00539220
• Device Catalogue Number: 3922
• Device Lot Number: 0029478563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• 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: 59 YR
• Patient Sex: Female