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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION CORDIS POWERFLEX PRO DILATATION CATH CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION CORDIS POWERFLEX PRO DILATATION CATH CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4400904S
Device Problem Break (1069)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)
Event Date 12/21/2020
Event Type  Injury  
Event Description
Patient was undergoing a lue arteriogram of a fistula; when the balloon was removed from the sheath, the sheath came apart and part of it came out on the balloon; bleeding was noted around the radial artery site and a hematoma started to form; sheath replaced; follow-up arteriogram was noted without any bleeding or hematoma noted. Fda safety report id# (b)(4).
 
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Brand NameCORDIS POWERFLEX PRO DILATATION CATH
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
miami lakes FL 33014
MDR Report Key11131553
MDR Text Key225813261
Report NumberMW5098709
Device Sequence Number1
Product Code LIT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Catalogue Number4400904S
Device Lot Number82165568
Was Device Available for Evaluation? Yes
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

Patient Treatment Data
Date Received: 01/06/2021 Patient Sequence Number: 1
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