MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE BALLOON CATHETER; GASTROINTESTINAL/TRACHEOBRONCHIAL BALLOON CATHETER

Model Number	B5-2C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature article: diagnostic yield of transbronchial cryobiopsy guided by radial endobronchial ultrasound and fluoroscopy in the radiologically suspected lung cancer: a single institution prospective study by vytautas ankudavicius, et al.Abstract transbronchial cryobiopsy (tbcb) is being studied in the diagnosis of peripheral lung lesions; however, there are only a few clinical studies around the world.The aim of our study was to evaluate the diagnostic values and safety of transbronchial cryobiopsy for radiologically suspected peripheral lung cancer.The prospective clinical study was executed from september 2019 to september 2021 at a tertiary clinical centre in lithuania.A total of 48 patients out of 102 underwent combined procedures of transbronchial forceps biopsy (tbfb) and tbcb.Diagnostic values and safety outcomes of tbfb and tbcb were analysed.The sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy were 72.9%, 100%, 100%, 7.7%, and 88.0% for tbfb, 85.1%, 100%, 100%, 12.5%, and 93% for tbcb, as well as 91.5%, 100%, 100%, 20.0% and 96.7% for the combined procedures, respectively, with a significantly higher accuracy for cryobiopsies compared to forceps biopsies (p < 0.05).The diagnostic values for transbronchial cryobiopsies were similar, irrespective of the radial mini probe endobronchial ultrasound (rp-ebus) position, lesion size or bronchus sign, however, the sensitivity of the combined procedures in cases with rp-ebus adjacent to the target was significantly higher compared to tbfb (86.2% vs.64.3%, p = 0.016).Samples of cryobiopsies were significantly larger than forceps biopsies (34.62 mm2 vs.4.4 mm2, p = 0.001).The cumulative diagnostic yield of transbronchial cryobiopsy was 80.0% after the second biopsy and reached a plateau of 84.1% after four biopsies.No severe bleeding, pneumothorax, respiratory failure or death was registered in our study.Tbcb is a potentially safe procedure, which increases diagnostic values in diagnosing peripheral lung lesions compared to tbfb.All patients had the tbfb and the following olympus devices were used: bf-h190, ums20-17s or um-s20-20r, standard oval biopsy forceps suitable for 2.0 mm scope channels.Not all patients had tbcb and the following olympus devices were used: bf-h190, a 5¿7 fr endobronchial blocker (olympus, japan) balloon was inflated to stop bleeding./gm-418500, 14apr2022.Adverse events: moderate bleeding after tbcb, n=2.This article includes 4 reports: (b)(6): bf-h190, scope and moderate bleeding (b)(6): unknown 5¿7 fr endobronchial blocker olympus balloon and moderate bleeding (b)(6): um-s20-20r or ums20-17s, ultrasonic probe and moderate bleeding; um-s20-20r was selected as a representative product.(b)(6): fb-231k, disposable biopsy forceps and moderate bleeding this report is 2 of 4: (b)(6): unknown 5¿7 fr endobronchial blocker olympus balloon and moderate bleeding.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Additional information received from the author: in the opinion of the author, the olympus device did not cause or contribute to the adverse event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the author.New information: b5, d1, d2, d3, d4, d10, g4.B3: corrected data.
Additional Manufacturer Narrative
Correction: g2.This report is being supplemented to provide a correction and additional information based on the legal manufacturer's final investigation.New information was added to the following fields: h4, h6, h10.H4: june 2021 (exact date is undetermined).The device history record was not reviewed as there was no reported device malfunction.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.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE BALLOON CATHETER
• Common Device Name: GASTROINTESTINAL/TRACHEOBRONCHIAL BALLOON CATHETER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14167255
• Report Number: 8010047-2022-06775
• Device Sequence Number: 5012439
• Product Code: EOQ
• UDI-Device Identifier: 04953170047398
• UDI-Public: 04953170047398
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K962901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2022

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: B5-2C
• Device Lot Number: 16K
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 05/11/2022; 06/30/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/10/2022; 07/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6) (LOT. 16V).; UNKNOWN SERIAL/LOT: (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown