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
Date of event: month and year was provided: (b)(6) 2019.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Ifu states: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire m and/or the catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the vessel." it is likely that that the actual sample was trapped by some factors; subsequently in that trapped state, it was subjected to external force beyond the product strength, resulting in the tip getting broken off.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.Please see mdr 2243441-2019-00103 for the importer report.(b)(4).
Event or Problem Description
Terumo medical received a user facility medwatch report # (b)(4).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: 9213421
• Report Number: 9681834-2019-00180
• Device Sequence Number: 16229622
• Product Code: DQX
• UDI-Device Identifier: 04987350711922
• UDI-Public: 04987350711922
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• 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