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

Model Number	M00545260
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block g2: the voluntary user medwatch number is (b)(4).Block h6: imdrf device code a0501 captures the reportable event of the sponge detached.
Event or Problem Description
It was reported to boston scientific corporation that rx locking / biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct for the treatment of dilated common bile duct and stone removal on (b)(6) 2024.During the endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician was unable to pass instruments through the working channel of the scope.They were also unable to instill contrast via dreamtome.They switched to a new scope, which was successfully used after a fifteen minute delay.Reportedly, during reprocessing, an endo tech discovered a sponge lodged in the working channel, identified as part of the rx locking/biopsy cap.The foam piece was removed by pushing multiple brushes down the biopsy channel.A water-soluble lubricant was not applied to the top of the biopsy cap, prior to use.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block g2: the voluntary user medwatch number is (b)(4).Block h6: imdrf device code a0501 captures the reportable event of the sponge detached.H2: correction made to h10, related medwatch 3500a report number added.
Event or Problem Description
It was reported to boston scientific corporation that rx locking / biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct for the treatment of dilated common bile duct and stone removal on (b)(6) 2024.During the endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician was unable to pass instruments through the working channel of the scope.They were also unable to instill contrast via dreamtome.They switched to a new scope, which was successfully used after a fifteen minute delay.Reportedly, during reprocessing, an endo tech discovered a sponge lodged in the working channel, identified as part of the rx locking/biopsy cap.The foam piece was removed by pushing multiple brushes down the biopsy channel.A water-soluble lubricant was not applied to the top of the biopsy cap, prior to use.There were no reported patient complications as a result of this event.

• Brand Name: RX LOCKING DEVICE AND BIOPSY CAP
• 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: 20359266
• Report Number: 3005099803-2024-04947
• Device Sequence Number: 7996269
• Product Code: ODC
• UDI-Device Identifier: 08714729746676
• UDI-Public: 08714729746676
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: M00545260
• Device Catalogue Number: 4526S
• Device Lot Number: 0033786468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 04/09/2024
• 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 Age: 87 YR
• Patient Sex: Female
• Patient Weight: 60 KG