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 Fever (1858); Hemorrhage/Bleeding (1888); Pain (1994); Sepsis (2067); Pancreatitis (4481)

Event Type  Injury  

Manufacturer Narrative

Unknown due to unknown lot number.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.Initial reporter name - requested, not provided.Establishment name - (b)(6).Health professional- requested, not provided.Occupation- requested, not provided.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 actual sample was not returned and the information that identifies the product such as a lot number was unknown.Since the lot number was unknown, the manufacturing record and the product release decision control sheet could not be reviewed.A search of the complaint file in the past 5 years (may 2017 to april 2022) found one similar report with the involved product code (ol-xa25455).As a result of confirming the details, the occurrence situation (according to the published literature, acute pancreatitis, and infectious disease after ercp were reported in the involved case) was different from this case.In addition, since the actual product was not returned and the lot number was unknown, the causal relationship between the involved product and the involved case was unknown.At the product design stage, the involved product has been confirmed for biological safety evaluation (cytotoxicity test, skin sensitization test, intradermal test, acute toxicity reaction, pyrogen test, hemolysis test) based on iso10993.Ashitaka factory regularly performs the following safety tests; i) indicator bacteria test, ii) endotoxinic test, iii) extraction test, iv) residual eo/ech test.Based on the investigation result, since the details of occurrence situation were unknown, and the defect of the device itself or the relationship between the device and the adverse event was not mentioned in the literature, it was not possible to clarify the causal relationship between the product and the reported issue.(b)(4).

Event Description

Per literature review eus guide - endoscopic transpapillary gallbladder drainage for the management of acute calculus cholecystitis patients unfit for urgent cholecystectomy: single-center retrospective study january 2021: adverse events include fever, abdominal pain, postoperative cholangitis, sepsis, acute pancreatitis, and hemorrhage have been reported as accidental symptoms.The involved product was described in the literature as the device used in the cases.However, the defect of the device itself or the relationship between the device and the adverse event were not mentioned in the literature.In the published paper, it was reported that there were adverse events such as fever occurred after surgery.The device used was a visiglide.There was no report of defect for the involved device.The patient had minor harm but did not have serious injury.

• 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: 14433597
• MDR Text Key: 292037057
• Report Number: 9681834-2022-00089
• 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,Literature,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: OL-XA25455
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/19/2022
• 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: GF-UCT260 (OLYMPUS); NA-U200H-8025 (OLYMPUS)
• Patient Outcome(s): Other