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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS COPORATION CATH MB 5F PIG 65CM 8SH FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS COPORATION CATH MB 5F PIG 65CM 8SH FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problems Detachment of Device or Device Component (2907); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2018
Event Type  Injury  
Manufacturer Narrative

It is not known if the device is available to be returned for analysis and no is selected in the report at this time. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

During withdrawal of a 5f 65cm supertorque plus pigtail diagnostic catheter from a tortuous and calcified iliac artery, there was ¿rupture of the probe at the level of the radiopaque markers and a piece of the probe remained in the patient. It was removed with a lasso. ¿ the device will not be returned for analysis.

 
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Brand NameCATH MB 5F PIG 65CM 8SH
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS COPORATION
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 Key8070269
MDR Text Key127120858
Report Number9616099-2018-02525
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK915836
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/03/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2020
Device MODEL NumberN/A
Device Catalogue Number532598C
Device LOT Number17694491
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/07/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/14/2018 Patient Sequence Number: 1
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