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

Model Number N/A

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2023

Event Type  malfunction  

Event Description

The user facility reported that while inspecting the single use guidewire before use, it was found that the coating had peeled off.In the center of guidewire, approximately 3cm of coating was missing.It was reported that there was no problem with using the product itself.The procedure had currently been ongoing (as of the time of receiving information on october 31).No harm to the patient was reported.The event occurred pre-treatment.No medical or surgical intervention was required.The procedure outcome was not reported.The final patient impact was not harmed.

Manufacturer Narrative

The actual device was not available; therefore, the actual device will not be returned for evaluation.Since the lot number was unknown, the investigation could not be performed.Since the lot number was unknown, the investigation could not be performed.In the past three years (as of december 2020 to november 2023) for the product with the involved product code, there have been no events caused by the manufacturing process.Since the actual sample was not returned, detailed investigation could not be performed, and the cause of occurrence could not be clarified.Relevant instructions for use (ifu) reference: "before use, prepare and inspect the instrument as instructed below.Should the slightest irregularity be suspected, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: SINGLE USE GUIDEWIRE
• 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18214824
• MDR Text Key: 329942715
• Report Number: 9681834-2023-00234
• 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: 11/28/2023

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 Model Number: N/A
• Device Catalogue Number: OL-XA25455
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/28/2023
• 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