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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL UNKSAVVY435 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL UNKSAVVY435 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number UNKSAVVY435
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 02/01/2008
Event Type  Injury  
Manufacturer Narrative
This article was found during a recent literature search of this device. Please note that patient specific details (demographics, medical history, and reason for intervention) are not available. The device is an unknown savvy balloon catheter and the catalog and lot numbers are not available. Kimiagar et al,. (2008). Carotid artery stenting in high risk patients with carotid artery stenosis not eligible for endarterectomy: clinical outcome after 5 years. , imaj ;10:121¿124. As reported by kimiagar et al. , (2008), carotid artery stenting in high risk patients with carotid artery stenosis not eligible for endarterectomy: clinical outcome after 5 years. , imaj ;10:121¿124; one procedural failure occurred in which the patient required a carotid ligation. The procedure was a carotid artery stenting that was performed with a low profile 4-20mm savvy balloon catheter, which was used for pre-dilatation after administration of 0. 6 mg atropine, and then a stent was deployed from the internal to the common carotid. The device was not returned for analysis. Additionally, as the sterile lot number was not available, device history record (dhr) reviews could not be performed. Given the limited information provided, the reported event ¿carotid ligation¿ could not be confirmed and the exact root cause could not be determined. A ligation is a surgical procedure of closing off a blood vessel or other duct or tube in the body by means of a ligature or clip. This procedure is often performed to control inadvertent bleeding. Vessel characteristics and procedural/handling factors may have contributed to the reported event. Additionally, usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling. Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process. Therefore, no preventative or corrective actions will be taken at this time.
 
Event Description
As reported by kimiagar et al. , (2008), carotid artery stenting in high risk patients with carotid artery stenosis not eligible for endarterectomy: clinical outcome after 5 years. , imaj ;10:121¿124; one procedural failure occurred in which the patient required a carotid ligation. The procedure was a carotid artery stenting that was performed with a low profile 4-20mm savvy balloon catheter, which was used for pre-dilatation after administration of 0. 6 mg atropine, and then a stent was deployed from the internal to the common carotid.
 
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Brand NameUNKSAVVY435
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8327322
MDR Text Key135869567
Report Number9616099-2019-02704
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKSAVVY435
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 Received01/16/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 02/11/2019 Patient Sequence Number: 1
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