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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiogenic Shock (2262)

Event Date 12/21/2021

Event Type  Death  

Event Description

Terumo medical received a letter from a law office stating that: (i) terumo products and/or devices were used or attempted to be used during a cardiac procedure and one or more of products and/or devices allegedly failed, individually and/or in combination with one another, causing alleged damages; (ii) the products and/or devices used was a terumo finecross catheter and runthrough ns extra floppy coronary guidewire, takeru ptca balloon dilatation catheter, and a glidewire hydrophilic coated guidewire; and (iii) decedent suffered catastrophic cardiac complications and died on (b)(6) 2021.The event occurred post procedure.It was reported that the patient didn't have any blood loss.There is a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.

• Brand Name: RADIFOCUS GLIDECATH HYDROPHILIC COATED CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 16260203
• MDR Text Key: 308343368
• Report Number: 2243441-2023-00003
• Device Sequence Number: 1
• Product Code: DQO
• 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: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2023
• Distributor Facility Aware Date: 12/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RUNTHROUGH NS EXTRA FLOPPY CORONARY GUIDEWIRE; TAKERU PTCA BALLOON DILATATION CATHETER; TERUMO FINECROSS CATHETER
• Patient Outcome(s): Death
• Patient Sex: Male