MAUDE Adverse Event Report: TERUMO CORPORATION IKARI 3.5 CATHETER IL3.5; CATHETER, INTRAVASCULAR DIAGNOSTIC

Device Problem Material Deformation (2976)

Patient Problem Discomfort (2330)

Event Date 01/16/2019

Event Type  malfunction  

Event Description

During a left heart catheterization via the right radial artery, the pt reported discomfort during removal of a terumo ikari 3.5 catheter.Upon removal it was noted that the catheter was kinked/crushed.

• Brand Name: IKARI 3.5 CATHETER IL3.5
• Type of Device: CATHETER, INTRAVASCULAR DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION; olathe KS 66061
• MDR Report Key: 8452232
• MDR Text Key: 139963288
• Report Number: MW5085140
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR