MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE ENDOSCOPIC WIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number RF*GA35263E

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and the shipping inspection record of the product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that during the procedure, the coating on the involved radifocus glidewire endoscopic wire was bad and it was protruding out.It was discovered while performing an ercp.There was no patient injury or death due the failure.It is believed that the procedure was completed with a similar item.There was no patient injury, medical/surgical intervention required.Additional information was received on 26mar2020.There was no coating broken off or left in the patient.The procedure was continued and completed with a second like device.

Manufacturer Narrative

This report is being submitted as follow up no.1.This reported event has been deemed not reportable based off the inspection of the actual sample; inspection of the returned sample upon receipt found that it does not have any separation of urethane layer.The device involved in this complaint has been verified to be the normal product; therefore, is not a reportable event.

• Brand Name: RADIFOCUS GLIDEWIRE ENDOSCOPIC WIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9961836
• MDR Text Key: 214801552
• Report Number: 9681834-2020-00058
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K151471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: RF*GA35263E
• Device Catalogue Number: EWR9035
• Device Lot Number: 191128
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1