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U.S. Department of Health and Human Services

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

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CORDIS CASHEL UNKSAVVY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number UNKSAVVY
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rupture (2208)
Event Date 01/31/2010
Event Type  Injury  
Manufacturer Narrative
Abdelhamid, m. , davies, r. , rai, s. , hopkins, j. , duddy, m. , & vohra, r. (2010). Below-the-ankle angioplasty is a feasible and effective intervention for critical leg ischaemia. European journal of vascular and endovascular surgery, 39(6), 762-768. Doi:10. 1016/j. Ejvs. 2010. 01. 027. In the literature article by abdelhamid, m. , davies, r. , rai, s. , hopkins, j. , duddy, m. , & vohra, r. (2010). Below-the-ankle angioplasty is a feasible and effective intervention for critical leg ischaemia. European journal of vascular and endovascular surgery, 39(6), 762-768. Doi:10. 1016/j. Ejvs. 2010. 01. 027; rupture of the treated artery occurred in one case, which did not require surgical intervention. The patient had critical limb ischemia. The procedure was a below the knee angioplasty in which a savvy balloon catheter was used to dilate the artery. The product was not returned for analysis. No lot number was provided therefore a product history record (phr) review could not be generated. There is no additional information regarding patient, lesion or procedural characteristics regarding this event. With the limited amount of information available and without the return of the product or films of the procedure, it is not possible to draw a clinical conclusion between the device and the event. However, vessel characteristics and procedural factors may have contributed to the reported event. Vessel damage, such as an arterial rupture, is a known potential adverse event associated with any procedure in which devices are introduced into the patient. Angioplasty of atherosclerotic vessels using balloon catheters have the potential to cause rupture or tearing of the target vessel. According to the instructions for use ¿balloon pressure should not exceed the rated burst pressure. The rated burst pressure is based on the result of in vitro testing. At least 99. 9% of the balloons (with a 95% confidence level) will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over pressurization. Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon. Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specified procedure for which the device will be used. ¿ as no lot number, catalogue code or other product information was supplied a phr could not be completed. The information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
 
Event Description
As reported in the literature by abdelhamid, m. , davies, r. , rai, s. , hopkins, j. , duddy, m. , & vohra, r. (2010). Below-the-ankle angioplasty is a feasible and effective intervention for critical leg ischaemia. European journal of vascular and endovascular surgery, 39(6), 762-768. Doi:10. 1016/j. Ejvs. 2010. 01. 027; rupture of the treated artery occurred in one case, which did not require surgical intervention. The patient had critical limb ischemia. The procedure was a below the knee angioplasty in which a savvy balloon catheter was used to dilate the artery.
 
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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 Key8332840
MDR Text Key135993656
Report Number9616099-2019-02708
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
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 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKSAVVY
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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: 02/12/2019 Patient Sequence Number: 1
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