• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CASHEL UNKSAVVY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number UNK-PTA CATHETERS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 03/01/2002
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) are not available. The device is an unknown savvy balloon catheter and the catalog and lot numbers are not available.   criado, f. J. , lingelbach, j. M. , ledesma, d. F. , & lucas, p. R. (2002). Carotid artery stenting in a vascular surgery practice. Journal of vascular surgery,35(3), 430-434. Doi:10. 1067/mva. 2002. 121209. As reported in the literary article by criado, f. J. , lingelbach, j. M. , ledesma, d. F. , & lucas, p. R. (2002). Carotid artery stenting in a vascular surgery practice. Journal of vascular surgery,35(3), 430-434. Doi:10. 1067/mva. 2002. 121209; report one patient had transient aphasia (beginning at the end of the cas procedure and resolving after 4 hours) and monoparesis of the hand, which resolved completely after 1 week. The indication for the cas was symptomatic (stroke, tia) ica stenoses. Initially, during the cas, a 0. 018-in sv-5 cordis small vessel guidewire was used to cross the ica lesion, which was then pre-dilated with a 4- by 40-mm savvy cordis balloon angioplasty catheter. Stenting involved placement of a self-expanding device from the ica across the bifurcation into the distal cca (across the origin of the eca). Post-balloon dilatation of the stent involved the use of a 4. 5- by 20-mm or 5- by 20-mm savvy balloon catheter. 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 ¿monoparesis¿ could not be confirmed and the exact root cause could not be determined. With the limited amount of information available and without return of the product for analysis or films of the event, it is not possible to draw a clinical conclusion between the device and the reported event. However, vessel characteristics and procedural factors may have contributed to the reported event. Monoparesis 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. 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 in the literary article by criado, f. J. , lingelbach, j. M. , ledesma, d. F. , & lucas, p. R. (2002). Carotid artery stenting in a vascular surgery practice. Journal of vascular surgery,35(3), 430-434. Doi:10. 1067/mva. 2002. 121209; report one patient had transient aphasia (beginning at the end of the cas procedure and resolving after 4 hours) and monoparesis of the hand, which resolved completely after 1 week. The indication for the cas was symptomatic (stroke, tia) ica stenoses. Initially, during the cas, a 0. 018-in sv-5 cordis small vessel guidewire was used to cross the ica lesion, which was then pre-dilated with a 4- by 40-mm savvy cordis balloon angioplasty catheter. Stenting involved placement of a self-expanding device from the ica across the bifurcation into the distal cca (across the origin of the eca). Post-balloon dilatation of the stent involved the use of a 4. 5- by 20-mm or 5- by 20-mm savvy balloon catheter.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKSAVVY
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 Key8328772
MDR Text Key135878658
Report Number9616099-2019-02705
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Other Health Care Professional
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 Model NumberUNK-PTA CATHETERS
Device Catalogue NumberUNK-PTA CATHETERS
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 Received01/15/2019
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
-
-