MAUDE Adverse Event Report: CORDIS CORPORATION SABERX RADIANZ; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	R51004004L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, the balloon of a 4mm x 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter ruptured during a pre-dilation inflation to nominal pressure.The device was replaced with a non-cordis balloon catheter to complete the procedure.There were no reported injuries to the patient.This was during a trans radial interventional (tri) procedure to treat a 90% stenosed external iliac artery lesion which had moderate calcification and mild tortuosity.The device was stored, handled, and prepped per the instructions for use (ifu) and there were no difficulties removing any of the sterile packaging components.The device was able to maintain negative pressure during preparation.A vassallo floppy guidewire was used and was able to cross the lesion.There were no issues removing the saberx radianz pta balloon catheter which was removed from the patient in one piece.The product was not returned for analysis.A product history record (phr) review of lot 82258854 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 likely contributed to the failure as described in the event reported.Calcification is known to damage balloon material; it is likely damage occurred during crossing or in the attempt to inflate the balloon at the 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.
Event or Problem Description
As reported, the balloon of a 4mm x 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter ruptured during a pre-dilation inflation to nominal pressure.The device was replaced with a non-cordis balloon catheter to complete the procedure.There were no reported injuries to the patient.This was during a trans radial interventional (tri) procedure to treat a 90% stenosed external iliac artery lesion which had moderate calcification and mild tortuosity.The device was stored, handled, and prepped per the instructions for use (ifu) and there were no difficulties removing any of the sterile packaging components.The device was able to maintain negative pressure during preparation.A vassallo floppy guidewire was used and was able to cross the lesion.There were no issues removing the saberx radianz pta balloon catheter which was removed from the patient in one piece.The device will not be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82258854 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 4mm x 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter ruptured during a pre-dilation inflation to nominal pressure.The device was replaced by an unknown kaneka balloon catheter to complete the procedure.There were no reported injuries to the patient.This was during a tri procedure to treat an external iliac artery lesion.A vassallo floppy guidewire was used and was able to cross the lesion.There were no issues removing the saberx radianz pta balloon catheter.The device will not be returned for evaluation.

• Brand Name: SABERX RADIANZ
• Common Device Name: 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 ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 19096249
• Report Number: 3007635982-2024-00101
• Device Sequence Number: 18044191
• Product Code: LIT
• UDI-Device Identifier: 20705032081761
• UDI-Public: 20705032081761
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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: 08/31/2025
• Device Catalogue Number: R51004004L
• Device Lot Number: 82258854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER (SHIDEN HP, KANEKA); UNKNOWN WIRE; VASSALLO FLOPPY
• Patient Sex: Unknown