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

Model Number	RF*GA38153A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant 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 product release decision control sheet of the product code/lot# combination was conducted with no findings.Please see mdr 9681834-2019-00140 for the manufacturer report.
Event or Problem Description
The user facility reported that the doctor was doing a percutaneous nephrolithotomy for a very extensive cast stone in the right kidney, there was a great deal of difficulty in getting guidewire access past the stones into the ureter (case previously failed), he had access with an 18ga x 15cm cook trocar needle and eventually attempted to cross using a gr3806 glidewire.He was unable to get the wire through the calyx to the ureter, contrast was injected to help with navigation, upon removing the wire it was noticed that the polyurethane jacket was sheared off leaving just the nitinol core wire for about the distal 5cm.He attempted access with another gr3806 wire and this time was able to get down the ureter; however, was unable to pass a 4fr kumpe catheter or dilator to be able to insert the scope to retrieve the jacket fragment and perform the lithotomy.The case was eventually aborted with the approximately 5cm portion of the jacket still in the patient.The doctor agreed that it was very likely the jacket of the wire was sheared off against the blunt metal cannula of the cook trocar needle due to perhaps becoming entrapped against a stone or possibly sticky from the contrast.The condition of the patient was unchanged from the start of the procedure and there has been no complication due to the material being left behind as of now.Additional information was received on 26jul2019.The patient's condition was unchanged; however, still needs the stones removed from her kidney and condition is no worse from the wire fragment.Additional information was received on 31july2019.The surgeon noticed that the protective sheath (coating) was missing for the last 2" of the wire.The doctor unsuccessfully tried to remove the piece.An x-ray was obtained to confirm the piece had broken off inside the patient.

• 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: 8855836
• Report Number: 2243441-2019-00061
• Device Sequence Number: 2716379
• Product Code: DQX
• UDI-Device Identifier: 04987350773357
• UDI-Public: 04987350773357
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2019
• Report Date (Section F): 08/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: RF*GA38153A
• Device Catalogue Number: GR3806
• Device Lot Number: 190219
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2019
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2019
• 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: 18GA X 15CM COOK TROCAR NEEDLE; FR KUMPE CATHETER AND DILATOR; GR3806 WIRE
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 08/02/2019