MAUDE Adverse Event Report: CORDIS US. CORP SABERX RADIANZ; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	R51007006L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 7mm x 6cm saberx pta (radianz) was used for the iliac artery.However, the device ruptured.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu.The device was prepped normally and was able to hold negative pressure.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.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion with the balloon cath.The catheter was noted to have been in an acute bend.The balloon catheter was never kinked while being used.The product was removed intact (in one piece) from the patient.The case was completed with the use of a non-cordis device.This was during an evt case.The product was not returned for analysis.A product history record (phr) review of lot 82257986 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors or vessel characteristics (although unknown) may have contributed to the reported event as the presence of calcification is known to cause damage to balloons.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 review nor the information provided 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.
Event or Problem Description
As reported, the 7mm 6cm saberx pta (radianz) was used for the iliac artery.However, the device ruptured.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu.The device was prepped normally and was able to hold negative pressure.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.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion with the balloon cath.The catheter was noted to have been in an acute bend.The balloon catheter was never kinked while being used.The product was removed intact (in one piece) from the patient.The case was completed with the use of a non-cordis device.This was during an evt case.The device was discarded due to infectious disease.

• Brand Name: SABERX RADIANZ
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 CR201-02 ; CS CR20102 ; 7863138372
• MDR Report Key: 18056589
• Report Number: 3007635982-2023-00323
• Device Sequence Number: 12481957
• Product Code: LIT
• UDI-Device Identifier: 20705032081457
• UDI-Public: (01)20705032081457(17)251031(10)82257986
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: R51007006L
• Device Lot Number: 82257986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown