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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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CORDIS CORPORATION SABER RX6MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51006030L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2022
Event Type  malfunction  
Event Description
As reported, the balloon of a 6mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its an initial inflation to 8 atmospheres (atm).As a result, an unknown device was used in place of the 6mm x 30cm 155cm saberx pta to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a lesion in the superficial femoral artery (sfa) which had a 90% stenosis, moderate calcification, mild tortuosity, and was not a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no difficulty advancing the balloon catheter towards the lesion and the device was able to cross the lesion without issue.The balloon catheter was never in an acute bend during this procedure, and it did not kink during its use.After the balloon ruptured, the balloon catheter was able to be removed easily and remained in one piece during its removal.Information regarding the patient, contrast used, contrast to saline ratio, and the replacement device used was requested but not provided, and the device was discarded and will not be returned for evaluation.
 
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of a 6mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its an initial inflation to 8 atmospheres (atm).As a result, an unknown device was used in place of the 6mm x 30cm 155cm saberx pta to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a lesion in the superficial femoral artery (sfa) which had a 90% stenosis, moderate calcification, mild tortuosity, and was not a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no difficulty advancing the balloon catheter towards the lesion and the device was able to cross the lesion without issue.The balloon catheter was never in an acute bend during this procedure, and it did not kink during its use.After the balloon ruptured, the balloon catheter was able to be removed easily and remained in one piece during its removal.Information regarding the patient, contrast used, contrast to saline ratio, and the replacement device used was requested but not provided, and the device was discarded and will not be returned for evaluation.
 
Manufacturer Narrative
After further review of additional information received.Complaint conclusion: as reported, the balloon of a 6mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its an initial inflation to eight atmospheres (atm).As a result, an unknown device was used in place of the 6mm x 30cm 155cm saberx pta to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a lesion in the superficial femoral artery (sfa) which had a 90% stenosis, moderate calcification, mild tortuosity, and was not a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no difficulty advancing the balloon catheter towards the lesion and the device was able to cross the lesion without issue.The balloon catheter was never in an acute bend during this procedure, and it did not kink during its use.After the balloon ruptured, the balloon catheter was able to be removed easily and remained in one piece during its removal.Information regarding the patient, contrast used, contrast to saline ratio, and the replacement device used was requested but not provided.The product was not returned for analysis.A product history record (phr) review of lot 82221003 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 moderate calcification with stenosis and mild tortuosity may have contributed to the reported event.Calcification is known to damage balloon material; it is likely this occurred when attempting to cross the severely stenosed lesion.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 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 RX6MM30CM155
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 Key14159248
MDR Text Key289698252
Report Number9616099-2022-05559
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032075326
UDI-Public(01)20705032075326(17)240430(10)82221003
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 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number51006030L
Device Lot Number82221003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Date Device Manufactured05/10/2021
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
UNK DEVICE
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