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

Model Number	RF*RB18303TA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
[medwatch 3600510000-2019-8024.].
Event or Problem Description
Terumo medical received a user facility medwatch report # 3600510000-2019-8024.The event description states: "during aortogram with right lower extremity runoff, physician was using a glidewire gold and the tip of the wire became lodged in plaque, in the patients right anterior tibial artery.The tip of the device broke off and remained in the plaque.Decision made to leave in".

• Brand Name: RADIFOCUS GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9213420
• Report Number: 2243441-2019-00103
• Device Sequence Number: 16240102
• Product Code: DQX
• UDI-Device Identifier: 04987350711922
• UDI-Public: 04987350711922
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2019
• Report Date (Section F): 10/21/2019

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: 12/31/2019
• Device Model Number: RF*RB18303TA
• Device Catalogue Number: GM1832
• Device Lot Number: 180115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/27/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2019
• 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
• Patient Age: 74 YR
• Patient Weight: 79
• Date Report Sent to FDA: 10/21/2019