MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number	OL-XS35273M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacturer date - unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the manufacturing record and the product release decision control sheet of the involved product code/lot# combination over the past three years (november 2018 to october 2021) confirmed that there were not any indications of anomaly in them.Review of the manufacturing record and the product release decision control sheet of the involved product code/lot# combination over the past three years (november 2018 to october 2021) confirmed that there were not any indications of anomaly in them.Review of the safety test result over the past three years confirmed that there were not any indications of anomaly in them.This product has undergone iso10993 compliant biological safety evaluation (cytotoxicity, skin sensitization, intracutaneous reaction, acute toxicity, pyrogen, hemolysis) at the product design stage.Safety test: in (b)(4) factory, the safety test is performed on a regular basis.Indicator bacteria test (iso 11135).Endotoxinic test (jp standard).Extraction test (disposable set standard for oxygenator).Residual eo, ech test (iso10993-7).It could not clarify the causal relationship with the involved product and could not identify the cause of occurrence.(b)(4).
Event or Problem Description
An article was published in an american scholarly journal (plosone).It was about a retrospective analysis of a total of 85 patients who underwent endoscopic retrograde cholangiopancreatography (ercp) and endoscopic ultrasound (eus) for suspected biliary stenosis at the samsung medical center in south korea.In that article, it was reported that there was post-procedure acute pancreatitis as adverse events.Since visiglide was included in the device used, it was taken up as compliments by our us subsidiary.However, there was no mention of the relationship between adverse events and visiglide, and there was no report of device malfunction.

• Brand Name: SINGLE USE GUIDWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13001149
• Report Number: 9681834-2021-00234
• Device Sequence Number: 17461395
• Product Code: OCY
• UDI-Device Identifier: 04953170282829
• UDI-Public: 04953170282829
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K091417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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 Catalogue Number: OL-XS35273M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/14/2021
• 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: TJF-260 DUODENOSCOPE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown