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

Model Number	M00540140
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a flexima nasobiliary catheter was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, performed on (b)(6) 2023.During preparation and upon unpacking, it was found that the pigtail of the device was fractured and could not be used.Another flexima nasobiliary catheter was opened and 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.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of pigtail detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a flexima nasobiliary catheter was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, performed on (b)(6) 2023.During preparation and upon unpacking, it was found that the pigtail of the device was fractured and could not be used.Another flexima nasobiliary catheter was opened and 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of pigtail detachment of device or device component.Block h10: the returned nasobiliary catheter was analyzed, and a visual evaluation noted that the pigtail was kinked in different parts and remains of use.A microscope inspection was performed to view the remains of use on the stent in more detail.No other problems with the device were noted.The reported complaint of tip of the device fractured could not be confirmed.Taking all available information into consideration, it is most likely that the technique applied during preparation and user manipulation while setting up the device through the endoscope could have contributed to the kinks along the pigtail.Therefore, the most probable root cause is adverse event related to the procedure.

• 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: 16481855
• Report Number: 3005099803-2023-01063
• Device Sequence Number: 5182455
• 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): 04/20/2023

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: 03/10/2025
• Device Model Number: M00540140
• Device Catalogue Number: 4014
• Device Lot Number: 0029028684
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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: 77 KG