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

Model Number	RF*RB18305TA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of the o.018 guidewire broke off in cbd during an exchange of equipment.The tip was left in the patient and was not able to be retrieved.Additional information was received on (b)(6) 2019.The patient was in stable condition and they were an outpatient.The wire tip was able to be located in the patient's cystic duct.Surgical intervention was reported to not be imminent.A biliary extraction balloon catheter was also used.

• 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: 8859752
• Report Number: 2243441-2019-00058
• Device Sequence Number: 16297972
• Product Code: DQX
• UDI-Device Identifier: 04987350712189
• UDI-Public: 04987350712189
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 08/05/2019
• Report Date (Section F): 08/05/2019

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: 02/29/2020
• Device Model Number: RF*RB18305TA
• Device Catalogue Number: GM1834
• Device Lot Number: 180319
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2019
• 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: 08/05/2019