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

Model Number	M00539250
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde appendicitis therapy (erat) procedure in the appendix on (b)(6) 2022.During the procedure, the stent could not be deployed.Another flexima biliary stent was used and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation finding of guide catheter detached/separated.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Medical device problem code a0401 captures the reportable investigation result of guide catheter detached/separated.The returned flexima biliary stent was analyzed, and a visual evaluation noted that the guide catheter was out of the push catheter and was detached.The guide catheter was bent, stretched and accordion.The suture and suture hole were in good conditions.Functional inspection could not be performed as the stent was not returned, therefore stent failure to deploy could not be confirmed.No other problems with the device were noted.Based on all the gathered information, investigation concludes that it is possible that the kinks presented on the guide catheter may be related to user manipulation during the procedure and/or during the preparation of the device.Once the push catheter presented kinks, the guide catheter may have been difficult to be pulled back, this may have led the user to apply technique and/or extra force that caused the guide catheter to stretch and accordion.As consequence of the extra force, the guide catheter detached.After the detachment of the guide catheter, the user may have pulled the guide catheter all the way out from the push catheter.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: 16311761
• Report Number: 3005099803-2023-00510
• Device Sequence Number: 12308206
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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: 09/28/2024
• Device Model Number: M00539250
• Device Catalogue Number: 3925
• Device Lot Number: 0028108244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Weight: 65 KG