MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE BILIARY DRAINAGE STENT V

Model Number	PBD-1030-1010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was torn off on one side and damaged in the patient when removing it with a snare (unknown manufacturer) after 12 weeks of endoscopic retrograde cholangiopancreatography (ercp) procedure.Follow-up confirmed that no additional surgery or additional intervention was required due to the damaged stent.There was no change in health status due to the reported event and patient was discharged.No additional trauma and no patient harm was reported due to the event.
Additional Manufacturer Narrative
The customer's allegation was confirmed.The stent was broken near the side flap at the proximal portion and the breakage area was stretched.The stent turned black near the distal portion.The subject device lot number is unknown, thus the manufacture date cannot be identified.Since the lot number of the subject device was unknown, a review of the dhr for the year prior to the event could not reveal any abnormalities related to the reported event.Based on the investigation results, it is likely that the stent was damaged due to the following mechanism: 1) during the retrieval of the stent, the stent near the side flap was pulled strongly using the sling.2) the pulling load was applied to the weak part, which is the notch of the side flap, which caused ductile fracture of the stent.It was unclear why the stent was pulled hard.However, the root cause of the reported event could not be determined.The instruction manual (drawing number: gk6896, revision number: 08) contains the following warnings and the detailed mechanisms are below.1) when withdrawing this instrument, confirm under x-ray that the inserted part of it is free from kinks and is not stuck in the stricture.Otherwise, it could cause patient injury, such as migration and dislocation of the stent.2) when retrieving this instrument from the bile duct, grasp a part avoiding the vicinity of side hole or side flap as much as possible, and slowly aligned with bile duct withdraw it with the endoscope observing fluoroscopic images.If a part around the side hole or side flap is strongly grasped by a snare or grasping forceps, or the stent is withdrawn with excessive force, this instrument may break and leave debris in the bile duct.3) do not retrieve this instrument in other methods than described in this instruction manual.Otherwise, it could cause migrating or falling off from the papilla and could damage the instrument.4) to retrieve the stent, use grasping forceps fg-44nr-1 in accordance with its instruction manual.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SINGLE USE BILIARY DRAINAGE STENT V
• Common Device Name: SINGLE USE BILIARY DRAINAGE STENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21444743
• Report Number: 9614641-2025-80014
• Device Sequence Number: 18111463
• Product Code: FGE
• UDI-Device Identifier: 04953170346170
• UDI-Public: 04953170346170
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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: PBD-1030-1010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SNARE (UNKNOWN MANUFACTURER).
• Patient Sex: Unknown