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

Catalog Number OL-XA25455

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pancreatitis (4481)

Event Date 03/27/2019

Event Type  Injury  

Event Description

An article titled "endoscopic ultrasonography-guided fine needle aspiration for extrahepatic cholangiocarcinoma: a safe tissue sampling modality" was published in mdpi journals.In the article, the incidence of adverse events in eus-fna and ercp tissue sampling was compared.Acute pancreatitis and infection were reported as adverse events that occurred after ercp.Since the product in question was included as the devices used in the case, it was taken up as a complaint.However, there is no mention regarding the relationship between the adverse events and the devices in the article, nor is there any report of a defect in the devices.The procedure outcome was not reported.The patient was harmed but non-serious.

Manufacturer Narrative

Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Manufacture date - unknown due to unknown lot number.The actual sample was discarded by the involved facility.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Since the involved lot number was unknown, review of manufacturing record or product-release judgement records could not be performed.Regarding the involved product code, no similar report was received over the past five years (march 2017 - february 2022).This product has undergone iso10993 compliant biological safety evaluation (cytotoxicity, skin sensitization, intradermal reaction, acute toxicity, pyrogen, and hemolysis) at the product design stage.Review of the safety test result over the past three years confirmed that there were not any indications of anomaly in them.Ashitaka conducts the following safety test regularly: indicator bacteria test, endotoxin test, extraction test, residual eo, ech test.According to the results of the investigation, there were no safety issues and no similar complaints have been received for the involved product code for the past 5 years (from march 2017 to february 2022).No causal link between the reported issue and the product in question was confirmed.(b)(4).

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13691542
• MDR Text Key: 286865296
• Report Number: 9681834-2022-00024
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OL-XA25455
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALOKA PRODUCT - SSD-5500; BOSTON SCIENTIFIC PRODUCT - M00535700; BOSTON SCIENTIFIC PRODUCT - M00550011; BOSTON SCIENTIFIC PRODUCT - M00556051; OLYMPUS PRODUCT - EU-ME2; OLYMPUS PRODUCT - FB-45Q-1; OLYMPUS PRODUCT - GF-UCT260; OLYMPUS PRODUCT - JF260V; OLYMPUS PRODUCT - KD-V411; OLYMPUS PRODUCT - M-0725&GF-UCT240; OLYMPUS PRODUCT - NA-U200H-8022