MAUDE Adverse Event Report: CORDIS CORPORATION SUPER TORQUE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 532-642

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2017

Event Type  malfunction  

Event Description

A mpa2 was opened, noticed the tip of the catheter was kinked.Requested a new one.The mpa2 was never inserted inside the patient.The patient was not affected by the defective equipment.It was never inserted inside the patient's body.New catheter was opened and the case proceeded with no other incidents.

• Brand Name: SUPER TORQUE
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 1820 mccarthy blvd; milpitas CA 95035
• MDR Report Key: 7024612
• MDR Text Key: 91822496
• Report Number: 7024612
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 532-642
• 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: 10/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR