MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA PROGREAT CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the radifocus catheter broke apart in the external carotid artery.The patient's condition was reported to be fine.The procedure was successful.Additional information was received on 05aug2019.The procedure was a visceral procedure.The broken piece was retrieved from the patient.The patient's condition was stable.

• Brand Name: PROGREAT CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 8931084
• Report Number: 2243441-2019-00077
• Device Sequence Number: 2129134
• Product Code: DQO
• UDI-Device Identifier: 04987350771810
• UDI-Public: 04987350771810
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2019
• Report Date (Section F): 08/26/2019

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: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: MC*PE28131YB
• Device Lot Number: 190422
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/31/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2019
• 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
• Date Report Sent to FDA: 08/26/2019