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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/31/2019

Event Type  Injury  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 8931084
• MDR Text Key: 155530306
• Report Number: 2243441-2019-00077
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350771810
• UDI-Public: 04987350771810
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2019
• Distributor Facility Aware Date: 07/31/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention