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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION / CREGANNA MEDICAL EMPIRA NC 3.5MM X 6MM CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY , PERCUTANEOUS

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CORDIS CORPORATION / CREGANNA MEDICAL EMPIRA NC 3.5MM X 6MM CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY , PERCUTANEOUS Back to Search Results
Catalog Number 75R06350N
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/10/2019
Event Type  malfunction  
Event Description
Portion of balloon catheter outside of body broke while catheter was in the body during coronary intervention. Fda safety report id# (b)(4).
 
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Brand NameEMPIRA NC 3.5MM X 6MM
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY , PERCUTANEOUS
Manufacturer (Section D)
CORDIS CORPORATION / CREGANNA MEDICAL
MDR Report Key9082457
MDR Text Key159315824
Report NumberMW5089865
Device Sequence Number1
Product Code LOX
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 09/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number75R06350N
Device Lot NumberCE1017870
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2019
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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