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

Model Number	M00545580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct.The procedure date is unknown.During the procedure, when the physician deployed the stent, the guide catheter detached from the deployment mechanism and had to be retrieved.The stent was deployed in place successfully and completed the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct.The procedure date is unknown.During the procedure, when the physician deployed the stent, the guide catheter detached from the deployment mechanism and had to be retrieved.The stent was deployed in place successfully and completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to june 01, 2022 based on the date the manufacturer became aware of the event.Block h6: medical device problem code a0401 captures the reportable event of guide catheter break.Impact code f23 captures the reportable event of unexpected medical intervention.Block h10: the returned flexima rx biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached and kinked.The push catheter was kinked.The push catheter was cut to verify the integrity of the working channel and it was found the guide catheter detached from the wire.Functional inspection could not be performed due the detachment of the guide catheter.No other problem with the device were noted.The reported event was confirmed.According to the product analysis, the device met all manufacturing requirements, and no abnormalities were reported during the manufacturing process; after analysis it was determined that the push catheter was kinked, the guide catheter returned detached and kinked.It is possible that user manipulation, some technique performed during procedure and/or even anatomical factors contributed on the device damages causing the kinks the push catheter and possibly submitting tension on the delivery system, while those conditions were present the user may have experienced difficulties during the retraction or extension of the guide catheter, and this may have taken the user to apply a different technique that ended kinked and detaching of the guide catheter.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.

• 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: 15090654
• Report Number: 3005099803-2022-03836
• Device Sequence Number: 17138312
• Product Code: FGE
• UDI-Device Identifier: 08714729337881
• UDI-Public: 08714729337881
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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: 02/16/2025
• Device Model Number: M00545580
• Device Catalogue Number: 4558
• Device Lot Number: 0028888250
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 07/24/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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