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

Model Number	M00545570
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing an ercp in the endoscopy suite.The device was introduced and according to staff, "the stent was deployed and (the) transducer on (the) stent fell off into (the) patient." the transducer was quickly retrieved with no harm coming to the patient.

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• MDR Report Key: 9086176
• Report Number: 9086176
• Device Sequence Number: 2819889
• Product Code: FGE
• UDI-Device Identifier: 08714729337874
• UDI-Public: (01)08714729337874(17)210403(10)21945512
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/04/2019
• Report Date (Section F): 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: M00545570
• Device Lot Number: 21945512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/04/2019