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

Model Number	M00545470
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	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.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 for the treatment of biliary stricture on (b)(6) 2024.During the beginning of an endoscopic retrograde cholangiopancreatography (ercp) procedure, the doctor passed the scope into the duodenum.Two plastic stents were noted: one in the bile duct and one in the pancreas and the doctor attempted to use a snare to retrieve the stents, but the snare could not advance, indicating a blockage in the scope's channel.The scope was removed, and a hedgehog brush was passed down the channel to investigate the blockage.Reportedly, some debris came out and it appeared to be dirty, it was found that the sponge from the locking device was dislodged and got stuck in the channel.There were no reported patient complications 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: 20748116
• Report Number: 3005099803-2024-05933
• Device Sequence Number: 8287338
• Product Code: ODC
• UDI-Device Identifier: 08714729746706
• UDI-Public: 08714729746706
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 11/21/2024

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: M00545470
• Device Catalogue Number: M00545470
• 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: 11/02/2024
• Initial Report FDA Received Date: 11/21/2024
• 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 Sex: Unknown