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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F BER II 65CM FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION CATH TEMPO 4F BER II 65CM FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number 451415V0
Device Problems Balloon (419); Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/28/2018
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17798728) presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

As reported, during a percutaneous nephrostomy (pcn) tube placement (pcn) exchange, two 4f tempo diagnostic catheters were used and the guide wire penetrated through. There was no reported patient injury. The devices will be return for evaluation.

 
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Brand NameCATH TEMPO 4F BER II 65CM
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
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 Key8000257
MDR Text Key124989775
Report Number9616099-2018-02457
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK973401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 05/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number451415V0
Device LOT Number17798728
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/31/2018
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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