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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 5.0X15 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL AVIATOR PLUS .014 5.0X15 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 4245015W
Device Problems Shaft; Crack; Catheter
Event Date 06/10/2019
Event Type  Malfunction  
Manufacturer Narrative

The 5. 0 x 15 aviator plus percutaneous transluminal angioplasty (pta) balloon catheter (bc) was used for the renal artery with a stent graft backup; however, the shaft of the aviator plus cracked while it was pushed to secure the renal artery. No patient injury was reported. The device was replaced with a new different length aviator plus and the procedure was continued. The intended treatment site and target lesion was the renal artery. The lesion had a little calcification, moderate angulation, and moderate tortuosity. The percentage of stenosis was seventy-five percent. The device was stored, handled, inspected, and prepped normally according to the instructions for use (ifu). The device was not used for a chronic total occlusion (cto). There were no kinks or other damages noted prior to inserting the product into the patient. There was no difficulty advancing the device to the target lesion. Excessive torquing was not required. There was no resistance met while advancing the device over the guidewire. There were no stents present within the treatment site or the tracking path. There was no resistance met while withdrawing the device. The product was removed intact (in one piece) from the patient. The device was not returned for analysis. A product history record (phr) review of lot 17550380 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿body/shaft cracked-in patient¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. However, vessel characteristics of calcification, moderate angulation, and tortuosity may have contributed to the reported event. The lesion is also described as having seventy-five percent stenosis, it is likely that during the attempt to cross the stenosed lesion damage may have occurred to the shaft of the catheter. According to the warnings in the instructions for use ¿prior to use, the device should be examined to verify functionality and integrity, and ensure that its size is suitable for the specific procedure. Caution: if strong resistance is met during advancement or withdrawal of the balloon catheter, discontinue movement and determine the cause of resistance before proceeding. If the cause of resistance cannot be determined, withdraw the entire system. Note: if the balloon cannot be withdrawn through the guiding catheter, withdraw the balloon catheter and guiding catheter as a single unit. ¿ neither the phr nor the information available suggests 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, the 5. 0x15 aviator plus percutaneous transluminal angioplasty (pta) balloon catheter (bc) was used for the renal artery with a stent graft backup, however the shaft of the aviator plus cracked while it was pushed to secure the renal artery. No patient injury was reported. The device was replaced with a new, different length aviator plus and the procedure was continued. The intended treatment site and target lesion was the renal artery. The lesion had a little calcification, moderate angulation, and moderate tortuosity. The percentage of stenosis was seventy-five percent. The device was stored, handled, inspected, and prepped according to the instructions for use (ifu), and it prepped normally. The device was not used for a chronic total occlusion (cto). There were no kinks or other damages noted prior to inserting the product into the patient. There was no difficulty advancing the device to the target lesion. Excessive torquing was not required. There was no resistance met while advancing the device over the guidewire. There were no stents present within the treatment site or the tracking path. There was no resistance met while withdrawing the device. The product was removed intact (in one piece) from the patient. The device will not be returned for evaluation as it was discarded in the hospital.

 
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Brand NameAVIATOR PLUS .014 5.0X15 142CM
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 Key8816115
Report Number9616099-2019-03091
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2019
Device Catalogue Number4245015W
Device LOT Number17550380
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 Received07/08/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/03/2016
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: 07/23/2019 Patient Sequence Number: 1
Treatment
AVIATOR PLUS
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