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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM20CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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CORDIS CORPORATION SABER RX5MM20CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51005020L
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2022
Event Type  malfunction  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, there was a leakage observed on the balloon of a 5mm x 20cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter.The leakage was found after an attempt to inflate the saberx pta balloon catheter was unsuccessful due to the fact the balloon could not maintain positive pressure when inflated to 8 atmospheres (atm).After the device was removed, the leakage was observed on the balloon near the guidewire exit port.As a result, an unknown balloon catheter was used in place of the 5mm x 20cm 155cm saberx pta balloon catheter to continue the procedure.There was no reported injury to the patient.The saberx pta balloon catheter was being used to treat a stenosed lesion in the left superficial femoral artery (sfa).Additional information was requested but was not provided, and the device will be returned for evaluation.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82232917 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
Complaint conclusion: there was a leakage observed on the balloon of a 5mm x 20cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter.The leakage was found after an attempt to inflate the saberx pta balloon catheter was unsuccessful due to the fact the balloon could not maintain positive pressure when inflated to 8 atm (eight atmospheres).After the device was removed, the leakage was observed on the balloon near the guidewire exit port.As a result, an unknown balloon catheter was used in place of the 5mm x 20cm 155cm saberx pta balloon catheter to continue the procedure.There was no reported injury to the patient.The saberx pta balloon catheter was being used to treat a stenosed lesion in the left superficial femoral artery (sfa).Additional information was requested but was not provided.The product was returned for analysis.A non-sterile saberx 5mm x 20cm 155 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a clear plastic bag.Per visual analysis, the balloon profile was inspected, and it appears to have been previously inflated.No anomalies in the body shaft of the unit were noted.Per functional analysis a lab sample inflator/ deflator device partially filled with water was attached to the inflation lumen of the unit and positive pressure was applied.A leakage was observed in the body shaft area near to the guide wire port of the unit.Per sem analysis the ruptured area near the guidewire port of the device presented evidence of elongations on the outer surface and scratch marks near the damaged area on the inner surface.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the inner surface led to the ruptured condition found on the device.It seems the material near the ruptured condition was torn due to the interaction of the unit with a sharp object from the inside of the device.No other anomalies were observed.A product history record (phr) review of lot 82232917 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft - leakage¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (although unknown) may have contributed to the event as evidenced by elongations and scratch marks noted on the outer surface during analysis.The reported ¿balloon-leakage - during positive pressure¿ was not confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
 
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: this device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, there was a leakage observed on the balloon of a 5mm x 20cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter.The leakage was found after an attempt to inflate the saberx pta balloon catheter was unsuccessful due to the fact the balloon could not maintain positive pressure when inflated to 8 atmospheres (atm).After the device was removed, the leakage was observed on the balloon near the guidewire exit port.As a result, an unknown balloon catheter was used in place of the 5mm x 20cm 155cm saberx pta balloon catheter to continue the procedure.There was no reported injury to the patient.The saberx pta balloon catheter was being used to treat a stenosed lesion in the left superficial femoral artery (sfa).Additional information was requested but was not provided, and the device will be returned for evaluation.Addendum: product evaluation on 08-jun-2022 reveled a leakage of the body/shaft of the 5mm x 20cm 155cm saberx pta balloon catheter.
 
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Brand Name
SABER RX5MM20CM155
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 Key14160786
MDR Text Key292841812
Report Number9616099-2022-05563
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032076002
UDI-Public(01)20705032076002(17)240831(10)82232917
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,Followup,Followup
Report Date 07/07/2022
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 Number51005020L
Device Lot Number82232917
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2021
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 BALLOON CATHETER; UNK GUIDEWIRE
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