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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 UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Event Date 01/01/2000
Event Type  Injury  
Manufacturer Narrative

As noted in a literature publication by ¿ishi, a. Et al. , (2000). Carotid stenting with the use of wallstent. Interventional neuroradiology 6 (suppl1): 181-185;¿ hypotension and bradycardia continued for >24 hours in one patient and he needed dopamine. Within forty-eight hours he recovered from hypotension. The procedure was a carotid artery stent case and a 3. 5-millimeters (mm) savvy balloon was used to dilate the lesion one or two times. The device was not returned for evaluation. Without a lot number available, the device history record (dhr) review for the device was unable to be conducted. Without the return of the devices for analysis or procedural films, the reported events could not be confirmed and the exact root cause could not be determined. Hypotension and bradycardia are well-known potential adverse events. Hypotension is the medical term for low blood pressure. Blood pressure is a measurement of the pressure in your arteries during the active and resting phases of each heartbeat. Causes of low blood pressure can range from dehydration to serious medical or surgical disorders. Bradycardia is a slower-than-normal heart rate. Bradycardia is often caused by a sudden increase in the activity of the vagus nerve. This is the nerve in the brain that help regulates the control of the heart, lung, and digestive tract. Once the vagal tone is restored to normal, the heart rate also returns to normal, so no permanent treatment of the bradycardia itself is required. These complication may occur at any time during or after the procedure and users are trained and experienced in how to treat this complication. Review of the information suggests that patient, procedural factors or other comorbidities may have contributed to the reported events. 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. Ishii, a. , mitsudo, k. , kikuta, k. , arakawa, y. , hojo, m. , goto, y. ,. Yamagata, s. (2000). Carotid stenting with the use of wallstent. Interventional neuroradiology, 6(1_suppl), 181-185. Doi:10. 1177/15910199000060s128. This article was found during a recent clinical evaluation review/literature search of this device. Please note that patient specific details (demographics, medical history and reason for intervention) are not available. The devices are savvy but the catalog and lot numbers are not available.

 
Event Description

As noted in a literature publication by ¿ishi, a. Et al. , (2000). Carotid stenting with the use of wallstent. Interventional neuroradiology 6 (suppl1): 181-185;¿ hypotension and bradycardia continued for >24 hours in one patient and he needed dopamine. Within forty-eight hours he recovered from hypotension. The procedure was a carotid artery stent case and a 3. 5mm savvy balloon was used to dilate the lesion one or two times.

 
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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 Key8349406
MDR Text Key136494250
Report Number9616099-2019-02729
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/19/2019
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 Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
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 Received01/23/2019
Was Device Evaluated By Manufacturer? No
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
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