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

Model Number	RF*GA35153A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received an fda medwatch report # 5089711.The event description states: "pt presented to ir for placement of bilateral nephrostomy tubes.During procedure guidewire sheared off and was retained in subq fat around kidney.Provider made pt and wife aware.No further interventions were necessary".

• 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: 9208549
• Report Number: 2243441-2019-00101
• Device Sequence Number: 3146503
• Product Code: DQX
• UDI-Device Identifier: 04987350773159
• UDI-Public: 04987350773159
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/18/2019
• Report Date (Section F): 10/18/2019

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*GA35153A
• Device Catalogue Number: GR3506
• Device Lot Number: 190218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/25/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 10/18/2019