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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

The device is mentioned in an article titled "risk factors for cholecystitis after metal stent placement for distal malignant biliary obstruction", in which an incident of acute cholecystitis was reported as an adverse event.There is no mention in the article about any malfunction of the device itself or a causal link between the adverse event and the device.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

Implanted date: device was not implanted, explanted date: device was not explanted, initial reporter name - requested, not provided.(b)(6).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 records or product-release judgement records could not be performed.Regarding the involved product code ol-xa25455, two similar reports had been received over the past five years (may 2017 - april 2022).Both reports were from published articles, the first case reported acute pancreatitis and infection after ercp, and the second case reported an incidental disease after eus-hgs.Therefore, the situation was different from this case in which acute cholecystitis was observed after sems implantation.In addition, in both cases, the causal link between the device and the cases was unknown, as the actual samples were not returned, and the lot numbers were unknown.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 based on the results of the investigation, it was confirmed that the article reported the results of research to identify the risk factors and clinical outcomes of acute cholecystitis after sems implantation, the acute cholecystitis was observed after sems implantation, and there was no mention of any defect in the device itself or a causal relationship between the device and the adverse event.From this, we concluded that there was not any causal link between the device in question and what was pointed out in this quality information.(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: 14565357
• MDR Text Key: 293103923
• Report Number: 9681834-2022-00099
• 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: 06/01/2022

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: 05/09/2022
• Initial Date FDA Received: 06/01/2022
• 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: JF-260V (OLYMPUS)
• Patient Outcome(s): Other