MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. PANCREATIC STENT; PANCREATIC DRAINAGE TUBE

Model Number	PBD-234-0812
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported upon removing a pancreatic stent that was in place for about a year, approximately 7 centimeters fell into the patients pancreatic duct.The subject device was retrieved from the patient.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (d4-lot number) and to provide an update to fields (b5 and h3).The subject device was manufactured on may 2022 based on the provided 3 digit lot information "25k".The device was evaluated by olympus, and the stent was broken near the side flap at the proximal portion and the breakage area was stretched.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the reported event might occur by the following mechanism: 1) the stent was pulled hard when removing it.2) the pulling load was applied to the stent, which caused ductile fracture of the stent.3) the broken stent was fallen off into the bile duct.However, it was unclear why the stent was pulled hard.Therefore, the root cause could not be identified.The event can be detected/prevented by following the instructions for use which state: "before withdrawing the stent make sure under x-ray that the inserted part of the stent is free from kinks and does not stick in the stricture.Withdrawing the stent forcibly, may cause parts of the stent to break off and remain in the patient.In case parts of the stent do remain, implement the appropriate treatment under the clinical judgement." "when retrieving the stent from the pancreatic duct, grasp a part of the stent avoiding the vicinity of the side hole or side flap as much as possible, and slowly withdraw it.When withdrawing the stent endoscopically with an endotherapy instrument, do it slowly along the pancreatic duct, while checking the x-ray images.If a part of the stent around the side hole or side flap is strongly grasped by a snare or grasping forceps, or the stent is withdrawn with excessive force, the stent may break and leave debris in the pancreatic duct." "if a surgical procedure is performed on the pancreatic duct of a patient with a stent placed in the duct, withdrawal of the stent may become difficult due to the effect, for example, of postoperative adhesion, ligation, etc.When the withdrawal of a stent is difficult, it must be removed according to the physician¿s clinical discretion." "do not forcibly withdraw the stent when removing it.It could damage the patient and the instrument." olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the reported event led to a 60-minute delay in the same case and about 60 minute in the next case (spyds) for retrieval of the subject device.The device was retrieved with spyds and spybite.

• Brand Name: PANCREATIC STENT
• Common Device Name: PANCREATIC DRAINAGE TUBE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18984154
• Report Number: 9614641-2024-00768
• Device Sequence Number: 2833209
• Product Code: FGE
• UDI-Device Identifier: 04953170152221
• UDI-Public: 04953170152221
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PBD-234-0812
• Device Lot Number: 25K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 06/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown