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

Model Number	M00545590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event : date of event was approximated to (b)(6) 2023 based on the date the manufacturer became aware of the event.Imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was to be used for an unknown procedure on an unknown date.During the procedure, inside the patient, the stent introducer broke upon stent deployment.The broken introducer was successfully removed from the patient with a pair of rat tooth forceps.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was to be used for an unknown procedure on an unknown date.During the procedure, inside the patient, the stent introducer broke upon stent deployment.The broken introducer was successfully removed from the patient with a pair of rat tooth forceps.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event was approximated to february 1, 2023, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2301 captures the reportable event of additional device required.Block h10: the returned flexima rx biliary stent was analyzed, and a visual evaluation noted that the push catheter was kinked at 30 cm from the proximal end.The guide catheter was not returned.A functional inspection was performed, and the handle was fully retracted and extended but the guide catheter did not come out from the push catheter, which is evidence of a guide catheter detachment.No other problems with the device were noted.According to the product analysis, the failure of the push catheter could have been caused by the technique used and the manipulation of the device during the procedure.The guide catheter not returned is restricting the possible reason of the device problem.The presence of this component is important to the investigation since the reported event was directly related to the guide catheter.Therefore, the most probable root cause is cause not established.

• Brand Name: RX 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: 16491042
• Report Number: 3005099803-2023-01072
• Device Sequence Number: 6758588
• Product Code: FGE
• UDI-Device Identifier: 08714729337898
• UDI-Public: 08714729337898
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2025
• Device Model Number: M00545590
• Device Catalogue Number: 4559
• Device Lot Number: 0029557440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown