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

Model Number	M00540140
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that aflexima nasobiliary catheter was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2022.During the preparation, when the device was checked, it was found that the tip of the catheter was broken and the guidewire could not be advanced.The physician attempted to straighten the catheter but it was about to fracture.Another flexima nasobiliary catheter was opened 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.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Block h6: medical device problem code a0501captures the reportable event of pigtail break.Block h6: the returned flexima nasobiliary catheter was analyzed, and a visual evaluation noted that there were no issues found on the device.The device was returned free of obvious kinks/bends.No other problem with the device were noted.The reported event was not confirmed.According to the product analysis, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It was determined that the device was free of obvious kinks/bends and during functional inspection it worked as intended, the unit returned did not show evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore, no problem detected is selected as the most probable root cause for the complaint.
Event or Problem Description
It was reported to boston scientific corporation that a flexima nasobiliary catheter was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2022.During the preparation, when the device was checked, it was found that the tip of the catheter was broken and the guidewire could not be advanced.The physician attempted to straighten the catheter but it was about to fracture.Another flexima nasobiliary catheter was opened 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.

• 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: 15586069
• Report Number: 3005099803-2022-05738
• Device Sequence Number: 2724259
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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: 01/02/2025
• Device Model Number: M00540140
• Device Catalogue Number: 4014
• Device Lot Number: 0028615939
• 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: 09/15/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 73 KG