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

Model Number	RF*ZV94110A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved glidecath broke off in the patient.Additional information was received on 16oct2019.While performing a peripheral angio of the right groin, going up and over in the left leg the glidecath broke off.The catheter was removed from the patient using a snare.The patient was reported to be stable.The procedure was completed successfully once removing the catheter.The blood loss was less than 250 cc's.

• 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: 9245238
• Report Number: 2243441-2019-00106
• Device Sequence Number: 3935282
• Product Code: DQO
• UDI-Device Identifier: 04987350772213
• UDI-Public: 04987350772213
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/28/2019
• Report Date (Section F): 10/28/2019

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: 02/28/2021
• Device Model Number: RF*ZV94110A
• Device Catalogue Number: CG416
• Device Lot Number: 180308
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/15/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2019
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 62
• Date Report Sent to FDA: 10/28/2019