MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE UROLOGIC WIRE; CATHETER, UROLOGICAL

Model Number	UWR1025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was not returned to the manufacturing facility for evaluation.Correction to section a5 ethnicity: not hispanic/lation was inadvertently selected.This should be blank & unselected.No evaluation could be conducted due to the device not being returned.There is no evidence that this event was related to a device defect or malfunction.With no return of the actual device the exact cause of the reported event cannot be definitively determined.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint files.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.See attached fda medwatch report no.(b)(4).Terumo medical product (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.- attachment: [(b)(4).Pdf].
Event or Problem Description
This report is being submitted in response to user facility medwatch report (b)(4) was received from the fda on september 14, 2017.The event description states the following: surgeon had difficulty getting initial wire through the left ureteral stricture.Surgeon did get access with a small wire and used the laser to open the stricture and get a larger wire in.The distal segment of the small wire was inadvertently broken off with the laser.Surgeon saw this after stent was positioned.Surgeon determined it to be in the patient's best interest to leave the wire inside the patient until the patient was brought back to remove the stent.Patient had a stent exchange about 2 months later and the wire was removed at that time.Additional information was received on 9/20/2017: it was reported that the patient condition was stable.The patient had the wire removed when the stent was exchanged at a later date.

• Brand Name: RADIFOCUS GLIDEWIRE UROLOGIC WIRE
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6915339
• Report Number: 9681834-2017-00215
• Device Sequence Number: 16258754
• Product Code: KOD
• UDI-Device Identifier: 04987350754592
• UDI-Public: 04987350754592
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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 Model Number: UWR1025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/05/2017
• 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: LARGER WIRE AND LASER; LARGER WIRE AND LASER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 102