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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO UNKVISTABRITEC CATHETER, PERCUTANEOUS

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CORDIS DE MEXICO UNKVISTABRITEC CATHETER, PERCUTANEOUS Back to Search Results
Model Number UNK-CARDIOLOGY GUIDING CATHETER
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Catheter (3038)
Patient Problem Transient Ischemic Attack (2109)
Event Date 01/01/2003
Event Type  Injury  
Manufacturer Narrative

This article was found during a recent clinical evaluation review/literature search of this device. The report also represents notification of two events for transient ischemic attack. Please note that patient specific details (demographics, medical history and reason for intervention) are not available. The devices are vista brite guiding catheters but the catalog and lot numbers are not available. The citation is as follows. A copy of the publication is attached to this report. As reported in the literature by moller-hartmann. , w. Et al. (2003). Carotid artery stenting with and without cerebral protection report of 43 procedures. Rivista di neuroradiologia 16: 1327-1329. (b)(6); report two cases of reversible neurologic symptoms (transient ischemic attack) were observed during carotid artery stenting (cas) procedures without cerebral protection while using an 8f or 9f vista brite tip guiding catheter for vascular access to the common carotid artery (cca). The guiding catheter was introduced via a transfemoral approach. The devices were not returned for analysis. A device history record (dhr) review could not be conducted as the sterile lot number was not provided. Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made. Tia is a well-known potential adverse event associated with the carotid stent implantation procedure and is listed in the ifu as such. Tia is often associated with a temporary stoppage or slowing of blood flow to the cerebral arteries. The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may collect in the embolic protection device or flow downstream potentially disrupting perfusion both during and after carotid stent implantation. By definition (mayoclinic. Org), the symptoms of a tia may last up to 24 hours, but they often last only a few minutes. Tia occurs when the blood supply to part of the brain is briefly interrupted. Tia symptoms are similar to those of stroke but do not last as long. Most symptoms of a tia disappear within an hour. There is no evidence that manufacturing issues contributed to the event. Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events. Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken.

 
Event Description

As reported in the literature by moller-hartmann. , w. Et al. (2003). Carotid artery stenting with and without cerebral protection report of 43 procedures. Rivista di neuroradiologia 16: 1327-1329. (b)(6); report two cases of reversible neurologic symptoms (transient ischemic attack) were observed during carotid artery stenting (cas) procedures without cerebral protection while using an 8f or 9f vista brite tip guiding catheter for vascular access to the common carotid artery (cca). The guiding catheter was introduced via a transfemoral approach.

 
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Brand NameUNKVISTABRITEC
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8569929
MDR Text Key143720603
Report Number9616099-2019-02888
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 05/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK-CARDIOLOGY GUIDING CATHETER
Device Catalogue NumberUNK-CARDIOLOGY GUIDING CATHETE
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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