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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION CATH ST 5F MP A2 (I) 125CM 2SH CATHETER, INTRAVASCULAR, DIAGNOSTIC

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CORDIS CORPORATION CATH ST 5F MP A2 (I) 125CM 2SH CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 532508
Device Problems Hub (469); Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/12/2018
Event Type  Malfunction  
Manufacturer Narrative

The product was not returned for analysis. Device history record (dhr) review was conducted and the product met quality requirements for product acceptance. This device is available for analysis but has not yet been received. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

During use of the angiographic multipurpose super torque catheter for transarterial chemoembolization, the physician reported that the catheter was stuck in the artery and then the hub was broken (cracked) during infusion. Additional information was received and there was resistance with the guidewire. There was no patient injury. The devices were removed successfully but with some difficulty. It happened with two catheters with the same lot numbers. The target was arteria hepatica which was slightly tortuous and the lesion was treated for total chronic occlusion in the past three month. The devices were prepped per the instruction for use (ifu) with no defects noted. A radial approach was used. A contralateral approach wasn't used. There were no difficulty tracking the device towards the lesion or through the vessel. The catheter has never been in an acute bend. The device was stored in the cath lab per the ifu. The product was not returned but is available as the lab has the sample.

 
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Brand NameCATH ST 5F MP A2 (I) 125CM 2SH
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8207918
MDR Text Key131773698
Report Number9616099-2019-02607
Device Sequence Number0
Product Code DTK
Combination Product (Y/N)N
PMA/PMN NumberK915836
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2019
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received01/02/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number532508
Device Catalogue Number532508
Device LOT Number17806388
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/12/2018
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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