MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE BILIARY BALLOON DILATOR

Model Number	BD-210N-0420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pancreatitis (4481)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not returned to olympus for evaluation.The literature did not describe any defects related to the product.Based on the legal manufacturer's investigation, it is considered that this event was not caused by a defect of the device.The cause could not be identified.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.
Event or Problem Description
Literature summary: the aim of the retrospective study was to evaluate the effects of endoscopic treatment in patients with secondary sclerosing cholangitis (ssc), the outcome of this disorder, and association with potential risk factor.There were 80 patients with ssc included in the study.Seventy-five patients (93.8%) underwent diagnostic endoscopic retrograde cholangiography; 46 patients (57.5%) could be treated endoscopically.Transplantation-free survival was affected neither by endoscopic treatment nor by presence of biliary strictures, but bacteria positive bile culture was associated with better and increased levels of serum alkaline phosphatase and bilirubin levels with poor outcome.This study concluded that secondary sclerosing cholangitis is a progressive disease with poor long-term prognosis.Endoscopic treatment options seem to be limited regarding transplantation-free survival but might improve quality of life and prevent local complications such as cholangitis.The associated types of adverse events / number of patients reported in the literature: death - 27 patients procedure-related complications: cholangitis - 8 patients post-ercp pancreatitis - 2 patients bleeding - 3 patients since the literature described "maxpass", and the actual product was unknown, "bd-210n-0420" was selected as a representative product for processing purposes.This report is being submitted for the cholangitis, post-ercp pancreatitis, and bleeding.It was reported in the literature that "no patient died due to complications associated with endoscopic procedures"; therefore, this report does not include the patient deaths.Additional details have been requested regarding the reported events.At this time, no additional information has been provided.
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 event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.This supplemental report includes corrections to g2 and h6.Information added to g2 and h6 (type of investigation) that was inadvertently not included on the initial medwatch.Also, a correction to h6 code (investigation findings).Code 114 (operational code) corrected to code 213 (no device problem).Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE BILIARY BALLOON DILATOR
• Common Device Name: BALLOON DILATOR
• 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: 15929491
• Report Number: 9614641-2022-00720
• Device Sequence Number: 15089062
• Product Code: FGE
• UDI-Device Identifier: 04953170399985
• UDI-Public: 04953170399985
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

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: BD-210N-0420
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/26/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown