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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 2MM15CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 2MM15CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 48002015X
Device Problems Shaft; Detachment of Device or device Component; Catheter
Event Date 02/27/2019
Event Type  Malfunction  
Manufacturer Narrative

The shaft of the saber 2mm x 15cm x 150cm was broken during the procedure. The target lesion was the superficial femoral artery (sfa). There were no reported patient injuries. The device was stored, handled and prepped normally, by maintaining negative pressure per the instructions for use (ifu). There were no anomalies noted to the device when it was taken out of the packaging. There was no difficulty removing the product from the packaging, removing the product from the hoop or removing the protective balloon cover. There were no kinks or other damages noted prior to inserting the product into the patient. There was no kinks/bends in the device. The saber was removed, and another balloon was used to complete the procedure. One product was returned for analysis. One non-sterile saber 2mm x 15cm x 150cm was returned for analysis. Per visual analysis, the balloon catheter was received coiled inside a plastic bag. The body/shaft is separated, the edges on the separation appear to be elongated. No original packaging was returned. No other anomalies were observed. Per microscopic analysis, elongations were observed along the edges of the separation of the body/shaft. Elongations are commonly associated with ruptures caused by material stretching force overload. Therefore, it is thought that the body/shaft was induced to a tensile force that exceeded the material yield strength prior to the separation. A product history record (phr) review of lot 17548911 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿body/shaft - separated in patient¿ was confirmed through analysis of the returned device. However, the exact cause of the separation could not be determined. During analysis, elongations were observed along the edges of the separated body. These elongations are commonly associated with ruptures caused by material stretching force overload. Therefore, the body/shaft was induced to a tensile force that exceeded the material yield strength. It is likely that procedural factors and handling of the catheter contributed to this separation. According to the safety information of the instructions for use ¿if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected. Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter. Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces. Always verify integrity of the catheter after removal. ¿ 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 shaft of the saber 2mm15cm 150 was broken during the procedure. There were no reported patient injuries. Additional information observed from the product analysis states that the body/shaft of the device was separated, and the edges of the separation looks elongated. The device was stored, handled and prepped per the instructions for use (ifu). The device was prepped normally by maintaining negative pressure. There were no anomalies noted to the device when it was taken out of the packaging. There was no difficulty removing the product from the packaging or removing the product from the hoop. There was no difficulty removing the protective balloon cover. There were no kinks or other damages noted prior to inserting the product into the patient. The body/shaft was separated. There was no kinks/bends in the device. The target lesion was the superficial femoral artery (sfa). The saber was removed and another balloon was used to complete the procedure. Additional procedural details were requested but are unknown.

 
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Brand NameSABER 2MM15CM 150
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 Key8802018
Report Number9616099-2019-03085
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2019
Device Catalogue Number48002015X
Device LOT Number17548911
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/21/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/28/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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