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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX5MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51005004L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2019
Event Type  Malfunction  
Manufacturer Narrative

A 5mm x 4 cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at five atmospheres (atm) while it was inflated at the lesion. There was no reported patient injury. It was noted that the product was used beyond expiration date. This was an endovascular therapy (evt) case. The target lesion was the iliac artery. The lesion had severe calcification. There was severe vessel tortuosity with 100% stenosis. The device was used for a chronic total occlusion (cto) >3 months. The device was stored and handled as per the instruction for use (ifu). There was no damage noted to the packaging of the device. The device was used and prepped normally (i. E. Maintain negative pressure) without anomalies. There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product into the patient. A non- cordis contrast media was used. A non-cordis inflation device was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter. The maximum inflation pressure was five atmospheres (atm). The balloon did not maintain pressure during inflation. There was no unusual force used at any time during the procedure. The product was removed intact (in one piece) from the patient. The use by date section was indicated in the outer product box and inner product package. There were no issues affecting the integrity of the outer product box and/or the inner package that impeded legibility of use by date section/expiration date (i. E. Stained, damaged/torn, creased). There was no specific circumstance that led to this incident of using an expired product. The procedure was completed using a non-cordis balloon catheter. Additional procedural details were requested but are unknown. The device was not returned for analysis as the device was discarded. A product history record (phr) review of lot 17616457 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, such as severe calcification, vessel tortuosity and stenosis, may have contributed to the reported event as calcification is known to damage balloon material. However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported. It is unclear as to why the device was used with an exceeded expiration date as this would be against the instructions for use. 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. Use the catheter prior to the ¿use by¿ date specified on the package. ¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event. Therefore, no corrective or preventive action will be taken at this time.

 
Event Description

As reported, a 5mm x 4 cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at 5 atmospheres (atm) while it inflated at the lesion. Therefore, it was replaced with another non-cordis balloon catheter and the procedure was completed. There was no reported patient injury. In addition, it was noted that the product was used beyond expiration date. The device was stored and handled as per the instruction for use (ifu). There was no damage noted to the packaging of the device. The device was used and prepped without anomalies. The device was prepped normally (i. E. Maintain negative pressure). There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. A non- cordis contrast media was used. A non-cordis inflation device was used successfully with other devices. This was an endovascular therapy (evt) case. The target lesion was the iliac artery. The lesion had severe calcification. There was severe vessel tortuosity with 100% stenosis. The device was used for a chronic total occlusion (cto) >3 months. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction while inserting the balloon through the guide catheter. The maximum inflation pressure was 5 atmospheres (atm). The balloon did not maintain pressure during inflation. There was no unusual force used at any time during the procedure. The product was removed intact (in one piece) from the patient. The use by date section was indicated in the outer product box and inner product package. There were no issues affecting the integrity of the outer product box and/or the inner package that impeded legibility of use by date section/expiration date (i. E. Stained, damaged/torn, creased). There was no specific circumstance that led to this incident of using an expired product. The device will not be returned as it was discarded by the hospital. Additional procedural details were requested but are unknown.

 
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Brand NameSABER RX5MM4CM155
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 Key9427492
MDR Text Key199105338
Report Number9616099-2019-03384
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,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/06/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2019
Device MODEL Number51005004L
Device Catalogue Number51005004L
Device LOT Number17616457
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 Received11/06/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/09/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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