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

Model Number	M00545620
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific that a flexima rx biliary stent was attempted to be placed during an endoscopic retrograde cholangiopancreatography (ercp) with plastic stent placement procedure in the duodenum and common bile duct performed on (b)(6) 2023.During the procedure, when the physician tried to place the stent over a dreamwire guidewire, the pull wire came out from the delivery system and out of the side of the flexima rx biliary stent.Additionally, it was reported that the push catheter and pull wire was kinked and that the guide catheter broke.The guide catheter was successfully removed in one piece.The procedure was successfully completed with another flexima rx biliary stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific that a flexima rx biliary stent was attempted to be placed during an endoscopic retrograde cholangiopancreatography (ercp) with plastic stent placement procedure in the duodenum and common bile duct performed on (b)(6) 2023.During the procedure, when the physician tried to place the stent over a dreamwire guidewire, the pull wire came out from the delivery system and out of the side of the flexima rx biliary stent.Additionally, it was reported that the push catheter and pull wire was kinked and that the guide catheter broke.The guide catheter was successfully removed in one piece.The procedure was successfully completed with another flexima rx biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401captures the reportable event of guide catheter broken.Block h10: the returned flexima rx biliary stent was analyzed, and a visual evaluation noted that the guide catheter was in good condition.The stent was not returned, and the pull wire was returned without kinks.Additionally, it was identified the push catheter was returned kinked and torn in the distal section and the pull wire was dislodge.The reported event of guide catheter was not confirmed.Taking all available information into consideration, the investigation concluded that most likely the reported event and observed failures were due to procedural factors encountered during the procedure.User manipulation and technique performed during the procedure could have contributed to the push catheter kink.Once the push catheter kinked, the user may have experienced difficulties removing the guide catheter, this may have led the user to apply additional force or tension causing the push catheter tear, the pull wire to dislodge from the push catheter and as a consequence failure to deploy the stent.Therefore, the most probable cause is adverse event related to the procedure.Block h11: corrected block e1 for initial reporter phone.Corrected block d6a for implant date.

• 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: 16659157
• Report Number: 3005099803-2023-01583
• Device Sequence Number: 7264095
• Product Code: FGE
• UDI-Device Identifier: 08714729337928
• UDI-Public: 08714729337928
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: 11/06/2025
• Device Model Number: M00545620
• Device Catalogue Number: 4562
• Device Lot Number: 0030496540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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 Sex: Unknown