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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION IKARI 3.5 CATHETER IL3.5 CATHETER, INTRAVASCULAR DIAGNOSTIC Back to Search Results
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.
 
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Brand NameIKARI 3.5 CATHETER IL3.5
Type of DeviceCATHETER, INTRAVASCULAR DIAGNOSTIC
Manufacturer (Section D)
TERUMO CORPORATION
olathe KS 66061
MDR Report Key8452232
MDR Text Key139963288
Report NumberMW5085140
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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