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

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The source of this report came from a registry and the following adverse event was found on review: the user facility reported that the patient had a mild spasm in the radial artery upon advancement of the 1.5 mm j wire.The patient was in stable condition.The procedure outcome was successful.There was no patient injury/medical or surgical intervention required.Additional information was received on 18 feb 2022: the procedure performed was a prostatic artery embolization (pae).There was no medication given to the patient.There were no other procedures performed to mitigate the issue.A large tr band was used after the procedure.

• 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: 13694933
• Report Number: 2243441-2022-00008
• Device Sequence Number: 1584738
• Product Code: DQX
• UDI-Device Identifier: 04987350707284
• UDI-Public: 04987350707284
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2022
• Report Date (Section F): 03/08/2022

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: GR3525
• Device Lot Number: 200629
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/17/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2022
• 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: 75 & 200 MICROSPHERES; FATHOM 14; GLIDESHEATH SLENDER; SYNCHRO-2; TR BAND - LARGE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 03/08/2022