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

Model Number	M00540140
Medical Device Problem Codes	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	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima nasobiliary catheter was to be used in the bile duct to treat a bile duct calculus during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, the tip of the catheter was noted to be lightly kinked upon unpacking.The procedure was completed with another flexima nasobiliary catheter.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on the investigation finding that the catheter was torn.Please see block h10 for the full investigation details.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is the first affiliated hospital of dalian medical university.Block h6: imdrf device code a0401 captures the reportable investigation finding of a torn catheter.Block h10: the flexima nasobiliary catheter was received for analysis.Visual inspection found that the catheter was torn into two pieces and not kinked.No other damages were noted with the catheter.Product analysis did not confirm the reported event of a catheter kink because visual inspection found that the catheter was not kinked; however, it was torn into two pieces.The investigation concluded that the catheter may have been torn during the process of opening the device's package during the preparation for the procedure or during the delivery of the device to the place where the procedure took place.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is the first affiliated (b)(6).Block h6: imdrf device code a0401 captures the reportable investigation finding of a torn catheter.Block h10: the flexima nasobiliary catheter was received for analysis.Visual inspection found that the catheter was torn into two pieces and not kinked.No other damages were noted with the catheter.Product analysis did not confirm the reported event of a catheter kink because visual inspection found that the catheter was not kinked; however, it was torn into two pieces.The investigation concluded that the catheter may have been torn during the process of opening the device's package during the preparation for the procedure or during the delivery of the device to the place where the procedure took place.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.Block h11: correction to the initial mdr in block h10.
Event or Problem Description
It was reported to boston scientific corporation that a flexima nasobiliary catheter was to be used in the bile duct to treat a bile duct calculus during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, the tip of the catheter was noted to be lightly kinked upon unpacking.The procedure was completed with another flexima nasobiliary catheter.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on the investigation finding that the catheter was torn.Please see block h10 for the full investigation details.

• Brand Name: FLEXIMA NASOBILIARY CATHETER
• 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: 18466017
• Report Number: 3005099803-2023-07037
• Device Sequence Number: 20631050
• Product Code: FGE
• UDI-Device Identifier: 08714729337409
• UDI-Public: 08714729337409
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K982508
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: 10/09/2025
• Device Model Number: M00540140
• Device Catalogue Number: 4014
• Device Lot Number: 0030311581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 140 KG