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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Biliary Cirrhosis (1736); Pancreatitis (4481)

Event Type  Injury  

Manufacturer Narrative

Date of death: unknown.Date of event: requested, not provided.Catalog number: requested, unknown.Lot number: requested, unknown.Expiration date: unknown due to unknown catalog and lot combination.Udi: n/a as this product code in not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Manufacture date - unknown due to unknown catalog and lot combination.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 no actual sample was returned and no information to identify the involved product code/lot was available, review of manufacturing record or product-release judgement records could not be performed.Regarding the representative product code, no similar report was received in the past five years (may 2017 - may 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.Ashitaka conducts the following safety test regularly: i) indicator bacteria test; ii) endotoxin test; iii) extraction test; iv) residual eo, ech test the literature studies evaluate the feasibility, efficacy, and safety of a new metal stent for the palliative treatment of malignant hilar bile duct stenosis (mhbs).As it does not mention any defects or adverse events associated with the product, no causal link between this complaint and the product was confirmed.(b)(4).

Event Description

Per literature review: "long slimmer metal stent is feasible and effective for endoscopic dual stent-by-stent placement in malignant hilar biliary stricture" (digestive diseases and sciences (2022) 67 1073-108), adverse events such as mild acute pancreatitis and cholangitis were reported.The use of a visiglide was mentioned, however the product type/code could not be identified.There was no reported problem with the product.It is unknown if there is a causal link between the adverse events and the product.The procedure outcome was not reported.The current patient condition is death.

• 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: 14590847
• MDR Text Key: 293263247
• Report Number: 9681834-2022-00105
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/03/2022
• 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: ACROBAT - WILSON-COOK MEDICAL; CLEVERCUT - OLYMPUS; F-260OR260V - OLYMPUS; JAGWIRE - BOSTON SC1ENT1FIC; NITI-ALLOY WOVEN MESH - MICRO-TECH; TJF-260OR240 - OLYMPUS
• Patient Outcome(s): Other; Death