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

Model Number	M00539220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, when the integrated biliary stent was placed normally, the inner core broke in the stent.After that, another new bracket was replaced.The event prolonged the operation time and increased the operation risk.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.The device will not be returned for analysis.
Additional Manufacturer Narrative
China user report notification reference number: (b)(4); submitted to the china competent authority, national medical products administration (nmpa).(b)(4).
Event or Problem Description
It was reported that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure, performed on (b)(6) 2022.According to the complainant, during the procedure, when the integrated biliary stent was placed normally, the inner core broke in the stent.After that, another new bracket was replaced.The event prolonged the operation time and increased the operation risk.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.The device will not be returned for analysis.Additional information received on october 25, 2022, and october 27, 2022: event information: the inner core of the guide catheter was found broken, outside the patient.Device outcome: unable to use.Out of box issue.Procedure outcome: procedure was completed with another flexima billary stent.Patient condition at the conclusion of the procedure: stable.
Additional Manufacturer Narrative
Block g2: china user report notification reference number: 120320100202203093; submitted to the china competent authority, national medical products administration (nmpa).Block h6: device code: a0401 is being used to capture the reportable issue of guide catheter break.Block h11: additional information blocks a1, a2, a3 and b5 have been updated based on the additional information received on october 25, 2022, and october 27, 2022.

• 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: 15637868
• Report Number: 3005099803-2022-06115
• Device Sequence Number: 5867549
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: 08714729162537
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 12/15/2024
• Device Model Number: M00539220
• Device Catalogue Number: 3922
• Device Lot Number: 0028571043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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: 63 YR
• Patient Sex: Male