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

Model Number	40-5023
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Adult male with history of htn, stemi and recent shortness of breath and swelling of lower extremities.Procedure: left heart cath.Terumo jackey radial removed from the package, in the original box that was kept on a shelf, and had a bend in the tubing.Not used on the patient.Manufacturer response for catheter, intravascular, diagnostic, optitorque (per site reporter).Will obtain.

• Brand Name: OPTITORQUE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 14336099
• Report Number: 14336099
• Device Sequence Number: 17464182
• Product Code: DQO
• UDI-Device Identifier: 04987350703521
• UDI-Public: (01)04987350703521(17)240731(10)210806
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/03/2022
• Report Date (Section F): 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40-5023
• Device Catalogue Number: RH*5BL3521A
• Device Lot Number: 210806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 97 KG
• Date Report Sent to FDA: 05/03/2022