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

Model Number 40-5023

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 04/27/2022

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 14336099
• MDR Text Key: 291204262
• Report Number: 14336099
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350703521
• UDI-Public: (01)04987350703521(17)240731(10)210806
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 05/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Male
• Patient Weight: 97 KG