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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3.5 100CM CATHETER, PERCUTANEOUS

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CORDIS CORPORATION 6F .070 XB 3.5 100CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number 67005400
Device Problems Device Markings/Labelling Problem (2911); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2019
Event Type  Malfunction  
Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, the 6f. 070 x 3. 5 x 100 cm vista brite tip guiding catheter (gc) extra back-up (xb) was found out by the physician that the catalogue number was wrong in the package. The actual device in the packaging was 7f guiding catheter (gc) instead of 6f guiding catheter (gc). There was no reported patient injury. Therefore, the procedure was completed by replacing another 6f guiding catheter (gc). Initially, the angiographic examination showed that the coronary artery is with stenosis that needed stent implantation. Then, the equipment who prepare the device gave it to the nurse and then, the nurse confirmed the quantity and opened the packaging one by one. As of note: ¿the hospital has reported this case as an adverse event¿.

 
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Brand Name6F .070 XB 3.5 100CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9274005
MDR Text Key198953868
Report Number9616099-2019-03320
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK021593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number67005400
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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