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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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CORDIS CORPORATION SABER RX6MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51006004L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
As reported, the balloon of a saber rx 6mm 4cm 155 ruptured at 16atm during second inflation after being inflated for 10 seconds.The procedure was completed after the use of a non-cordis balloon catheter of the same size.There was no reported injury to the patient.An approach was made from the left common femoral artery for a lesion in the right external iliac artery.A unknown guidewire crossed the lesion and the saber balloon was used for pre-dilation.The balloon was inflated to 16atm for 30 seconds during initial inflation.The device will not be returned for evaluation as it was discarded.Additional information was requested; however, the information could not be obtained.
 
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of a saber rx 6mm 4cm 155 ruptured at 16atm during second inflation after being inflated for 10 seconds.The procedure was completed after the use of a non-cordis balloon catheter of the same size.There was no reported injury to the patient.An approach was made from the left common femoral artery for a lesion in the right external iliac artery.A unknown guidewire crossed the lesion and the saber balloon was used for pre-dilation.The balloon was inflated to 16atm for 30 seconds during initial inflation.The device will not be returned for evaluation as it was discarded.Additional information was requested; however, the information could not be obtained.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82222005 presented no issues during the manufacturing process that can be related to the reported event.As reported, the balloon of a saber rx 6mm 4cm 155 ruptured at 16atm during second inflation after being inflated for 10 seconds.The procedure was completed after the use of a non-cordis balloon catheter of the same size.There was no reported injury to the patient.An approach was made from the left common femoral artery for a lesion in the right external iliac artery.An unknown guidewire crossed the lesion, and the saber balloon was used for pre-dilation.The balloon was inflated to 16atm for 30 seconds during initial inflation.Additional information was requested; however, the information could not be obtained.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82222005 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 and procedural factors likely contributed to the reported event.However, with the limited amount of information available regarding lesion characteristics and 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 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 or preventive action will be taken at this time.
 
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Brand Name
SABER RX6MM4CM155
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key14013991
MDR Text Key290463022
Report Number9616099-2022-05520
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032076101
UDI-Public(01)20705032076101(17)240531(10)82222005
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number51006004L
Device Catalogue Number51006004L
Device Lot Number82222005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Date Device Manufactured06/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BALLOON CATHETER (STERLING, BOSTON SCIENTIFIC).; UNK GUIDEWIRE.
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