MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "guidewire malposition outside the bile duct during endoscopic ultrasound-guided hepaticogastrostomy".Endoscopic ultrasound-guided hepaticogastrostomy (eus-hgs) is widely used in clinical practice for patients with a malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatography (ercp) however, the rate of procedure-related adverse events associated with eus-hgs is relatively high.Herein, we report a case of guidewire malposition during eus-hgs.An 80-year-old man with biliary obstruction due to pancreatic cancer was referred to our hospital for eus-hgs because of prior ercp failure.During the procedure, the bile duct of segment 3 was punctured using a 19-g needle (ez shot 3 plus; olympus medical, tokyo, japan), and contrast medium was injected into the bile duct.A guidewire (visi- glide 2 guidewires; olympus medical) was advanced toward the biliary tract without resistance.After dilation of the fistula, contrast was noted outside the bile duct, suggesting guidewire malposition.Eus-hgs on the bile duct of segment 2 was performed for salvage drainage.After the guidewire was inserted into the biliary tract and fistula dilation was performed, a fully covered selfexpandable metal stent (x-suit nir biliary metallic stents; olympus medical) was inserted.Although the post-eus-hgs computed tomography showed hematomas around the liver and spleen, the patient was discharged from our hospital after conservative treatment.The probable cause of incorrect advancement of the guidewire was incomplete placement of the needle tip within the bile duct.As a result, although the contrast medium was injected into the bile duct, the guidewire migrated outside the bile duct.Fluoroscopy showed that the two guidewires had a similar shape; however, their loop widths were different.Recent advances have enabled eus-hgs to be performed without fistula dilation, using a self-expandable metal stent with a small-diameter delivery system.It is necessary to evaluate the shape of the guidewire before stent placement during eus-hgs without fistula dilation.Type of adverse events/number of patients hematomas around the liver and spleen - (1).Although the post-eus-hgs computed tomography showed hematomas around the liver and spleen, the patient was discharged after conservative treatment.
Additional Manufacturer Narrative
Since the literature described "ez shot 3 plus", olympus selected "na-u200h-8019" as a representative product.The suspect device has not been returned to olympus for evaluation.The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.In addition, the malfunction of the device has not been reported, and from clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• 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: 17465696
• Report Number: 9614641-2023-01092
• Device Sequence Number: 11409152
• Product Code: FCG
• UDI-Device Identifier: 04953170380402
• UDI-Public: 04953170380402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: NA-U200H-8019
• Was Device Available for Evaluation?: No
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male