MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	RF*ZB5410GA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor was trying to pull the catheter over a wire and the catheter snapped in to multiple pieces.The patient was reported to be in stable condition.The procedure outcome was successful.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATH.
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9460826
• Report Number: 2243441-2019-00121
• Device Sequence Number: 16916816
• Product Code: DQO
• UDI-Device Identifier: 04987350772077
• UDI-Public: 04987350772077
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/12/2019
• Report Date (Section F): 12/12/2019

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: 03/31/2022
• Device Model Number: RF*ZB5410GA
• Device Catalogue Number: CG409
• Device Lot Number: 190422
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/14/2019
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2019
• 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: 12/12/2019