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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION CATH NYLEX 4F PIG 110CM 8SH FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION CATH NYLEX 4F PIG 110CM 8SH FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 526413
Device Problems Shaft (955); Detachment of Device or Device Component (2907); Catheter (3038)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2018
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, when entering the 4f pig catheter (cath nylex 4f pig 110cm 8sh) in the introducer, the tip bent. When disposing it, the catheter separated in two. There was no reported patient injury. The product will not be returned for analysis.

 
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Brand NameCATH NYLEX 4F PIG 110CM 8SH
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
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 Key8055978
MDR Text Key128791892
Report Number9616099-2018-02510
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK971646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 06/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2020
Device MODEL Number526413
Device Catalogue Number526413
Device LOT Number17664660
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 Received12/07/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/17/2017
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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