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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
Model Number UNK-PTA CATHETERS
Device Problems Balloon (419); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); No Code Available (3191)
Event Date 05/01/2001
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 sv 0. 018 guidewire and the catalog and lot numbers are not available. Qureshi a. , i. (2001). Open-label phase i clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and stent placement. Neurosurgery, vol. 48, no. 5. As reported in the literature by qureshi a. , i. (2001). Open-label phase i clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and stent placement. Neurosurgery, vol. 48, no. 5. ; an angioplasty was performed with a 3. 5x40 savvy pre-stent balloon and intraoperative and postoperative hypotension requiring dopamine for 8 hours, intraoperative bradycardia, and insignificant bleeding occurred in patient 6. The patient had a decrease in hemoglobin from 10. 1 g/dl to 8. 8 g/dl. Although the decrease in hemoglobin was small, the patient was provided 1 unit of packed red blood cells to facilitate treatment of hypotension because of low pre-procedure hemoglobin. The hypotension was predominantly attributable to baroreceptor manipulation. The patients maximum activated coagulation time was 298. A non-cordis 8x40 stent was placed, and a non-cordis vascular closure device (vcd) was used. The patient¿s total hospital stay was five days. The device was not returned for analysis. A review of the manufacturing documentation associated with precise lot number presented no issues during the manufacturing process that can be related to the reported complaint. The sterile lot number of the savvy device was not provided; therefore, no review of manufacturing documentation could be performed. Given the limited information provided, the reported event ¿hypotension, bradycardia and bleeding¿ 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. Bleeding is a common procedural complication and are frequently related to stick technique, anticoagulation, blood pressure and/or discomfort during and after the procedure. Patient and/or pharmacological factors are also likely contributing factors. Hypotension and bradycardia are well-known potential adverse events associated with the carotid stent implantation procedure. The hemodynamic instability that occurs both during and after carotid stent implantation is influence by the baro-receptors, which are located at the carotid bifurcation. These baro-receptors are stimulated by the stretch of interventional balloons, sds, and distal protection devices, initiating a reflex via the glossopharyngeal nerve. This results in a fall in blood pressure and bradycardia. Stent placement may promote persistent stimulation of these baro-receptors. These reactions are anticipated relatively short-term adverse events. There is no evidence that the event was related to a manufacturing issue, therefore, no corrective action will be taken. Without a lot number to conduct a device history record (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 literature by qureshi a. , i. (2001). Open-label phase i clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and stent placement. Neurosurgery, vol. 48, no. 5. ; an angioplasty was performed with a 3. 5x40 savvy prestent balloon and intraoperative and postoperative hypotension requiring dopamine for 8 hours, intraoperative bradycardia, and insignificant bleeding occurred in patient 6. The patient had a decrease in hemoglobin from 10. 1 g/dl to 8. 8 g/dl. Although the decrease in hemoglobin was small, the patient was provided 1 unit of packed red blood cells to facilitate treatment of hypotension because of low pre procedure hemoglobin. The hypotension was predominantly attributable to baroreceptor manipulation. The patients maximum activated coagulation time was 298. A non-cordis 8x40 stent was placed, and a non-cordis vascular closure device (vcd) was used. The patients total hospital stay was five days.

 
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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 Key8350812
MDR Text Key136513268
Report Number9616099-2019-02732
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072947
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,Followup
Report Date 03/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received01/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 02/19/2019 Patient Sequence Number: 1
Treatment
NON-CORDIS 8X40 STENT; NON-CORDIS VASCULAR CLOSURE DEVICE
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