MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	RF*PA35183A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional 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 product-release judgement of the involved product code/lot# combination was conducted with no findings.(b)(4) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that the involved radifocus was used during the procedure.During use for the gj tube exchange, once the wire entered the gj tract in less than two minutes, the hydrophilic coating wore off.The patient's condition was stable.The procedure outcome was successful.There was no patient injury, medical/surgical intervention required.Additional information was received 07jul2020.The coating of glidewire did not shear off.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection revealed no obvious anomalies including a bend along the shaft.Lubricity performance of the shaft was evaluated.As a result, high resistance (low lubricity performance) was observed 150mm - 600mm from the distal end.Electron microscopic inspection of the surface where high resistance was observed obtained the following findings.Some scratches on the surface, the hydrophilic coating had been abraded off.Based on this, it is likely that the actual sample was exposed to some kind of external load.Magnifying inspection of the area other than the high resistance area confirmed that the urethane outer layer was intact.Electron microscopic inspection of the area other than the high resistance area found the peculiar cracked pattern indicating the presence of the hydrophilic coating on the surface.The outer diameter of the area other than the high resistance area was measured and confirmed to meet the factory's control criteria.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the actual sample, after shipped from the factory, may have been exposed to some kind of load that caused to hydrophilic coating to be abraded off.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10313996
• Report Number: 9681834-2020-00143
• Device Sequence Number: 11321343
• Product Code: DQX
• UDI-Device Identifier: 04987350773630
• UDI-Public: 04987350773630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: RF*PA35183A
• Device Catalogue Number: GS3509
• Device Lot Number: 200110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GJ TUBE