MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX LOCKING DEVICE; ENDOSCOPE CHANNEL ACCESSORY

Model Number	M00545471
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an rx locking and biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure when passing a piece of equipment through the biopsy port the sponge dislodged and was lodged in the scope.The procedure was completed with a new scope and another rx locking and biopsy cap rx locking.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Block b5 was updated based on additional information received from medwatch that the event/procedure date is (b)(6) 2022, and the patient was not harmed but the procedure lasted longer because the scope had to be switched out to complete the procedure.The sponge was retrieved in the scope cleaning room.Block h6: device code a0501 captures the reportable event of the sponge detached.
Event or Problem Description
It was reported to boston scientific corporation that an rx locking and biopsy cap was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure when passing a piece of equipment through the biopsy port the sponge dislodged and was lodged in the scope.The procedure took longer because the scope had to be replaced with a new scope, another rx locking, and a biopsy caps rx locking to complete the procedure.The sponge was retrieved in the scope cleaning room.There were no patient complications reported as a result of this event.

• Brand Name: RX LOCKING DEVICE
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• 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: 15941122
• Report Number: 3005099803-2022-07074
• Device Sequence Number: 6200756
• Product Code: ODC
• UDI-Device Identifier: 08714729337768
• UDI-Public: 08714729337768
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K010610
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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 Model Number: M00545471
• Device Catalogue Number: 4547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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