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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX5MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51005010L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2019
Event Type  malfunction  
Manufacturer Narrative
Complaint conclusion: a saber rx (5mm x 10cm x 155cm) percutaneous transluminal angioplasty (pta) balloon catheter was delivered and inflated to six atmospheres (atm); however, pressure could not be applied at 14 atm during its second inflation. The lesion was the left superficial femoral artery which had severe stenosis. The device was removed from the patient¿s body and balloon rupture was confirmed. Therefore, it was replaced with a new non-cordis balloon catheter and it was inflated to 14 atm. A guide wire crossed the lesion and the procedure was completed by drug-coated balloon performance. There was no reported patient injury. The product was not returned for analysis. A product history record (phr) review of lot 17657904 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. Vessel characteristics of severe stenosis may have contributed to the reported event. However, without the return of the product for analysis it is difficult to draw a clinical conclusion between the device and reported event. According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used. Do not use if product damage is suspected or evident. To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion. The balloon dimensions are printed on the product label. The compliance table incorporated with the product shows how balloon diameter increases as pressure increases. Do not exceed the rated burst pressure recommended on the label. The rated burst pressure is based on the results of in vitro testing. At least 99. 9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over-pressurization. Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath. Balloon rupture can cause vessel damage and the need for additional intervention. Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline). Never use air or any gaseous medium to inflate the balloon. ¿ 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, a saber rx (5mm10cm155) percutaneous transluminal angioplasty (pta) balloon catheter was delivered and inflated at 6 atmospheres (atm); however, pressure could not be applied at 14 atm during its second inflation. The device was removed from the patient body. Balloon rupture was confirmed; therefore, it was replaced with a new non-cordis balloon catheter and it was inflated at 14 atm. The procedure was completed by a drug-coated balloon performance. There was no reported patient injury. The lesion was the left superficial femoral artery which had severe stenosis. A guide wire crossed the lesion. The device was clinically used but will not be returned for analysis because of infectious disease.
 
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Brand NameSABER RX5MM10CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI
Manufacturer (Section G)
CORDIS CASHELS
cahir road
cashel, co. tipperary
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8785859
MDR Text Key150866963
Report Number9616099-2019-03074
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model Number51005010L
Device Catalogue Number51005010L
Device Lot Number17657904
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2017
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: 07/12/2019 Patient Sequence Number: 1
Treatment
UNKNOWN BALLOON CATHETER
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