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Model Number 51006025L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2019
Event Type  malfunction  
Manufacturer Narrative
As reported, a 6mm x 25cm 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter ruptured at four atmospheres (atm). There was no reported patient injury. The target lesion was the superficial femoral artery. The device was replaced with another saber pta balloon catheter. The device was not returned for analysis as the device was discarded due to the patient¿s infectious disease. A product history record (phr) review of lot 17620008 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, although unknown, may have contributed to the reported event. However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported. 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. 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 or preventive action will be taken at this time.
Event Description
As reported, a 6 mm x 25 cm 155¿ saber rx percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at 4 atmospheres (atm). Therefore, it was replaced with another saber pta balloon catheter. There was no reported patient injury. The lesion was the superficial femoral artery. The device will not be returned for analysis as it was discarded due to infectious disease.
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Brand NameSABER RX6MM25CM155
Manufacturer (Section D)
cahir road
cashel, co. tipperary
Manufacturer (Section G)
cahir road
cashel, co. tipperary
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key9365855
MDR Text Key198972241
Report Number9616099-2019-03369
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 11/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model Number51006025L
Device Catalogue Number51006025L
Device Lot Number17620008
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 Received10/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial