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

Catalog Number	R51006004L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 6mm x 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its initial inflation.A new saberx radianz pta balloon catheter was used as a replacement and a smart radianz self-expanding stent (ses) was implanted to complete the procedure.There were no reported injuries to the patient.This was during a trans-radial intervention (tri) procedure to treat a 90% stenosed iliac lesion which had mild calcification and mild tortuosity.An approach was made from the left radial artery with a brite tip radianz catheter sheath introducer (csi).A vassallo floppy 18 guidewire was used to cross the lesion and an intravascular ultrasound (ivus) was performed prior to the use of the saberx radianz pta balloon catheter.The device was discarded and will not be returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, the balloon of a 6mm x 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its initial inflation.A new saberx radianz pta balloon catheter was used as a replacement and a smart radianz self-expanding stent (ses) was implanted to complete the procedure.There were no reported injuries to the patient.This was during a trans-radial intervention (tri) procedure to treat a 90% stenosed iliac lesion which had mild calcification and mild tortuosity.An approach was made from the left radial artery with a brite tip radianz catheter sheath introducer (csi).A vassallo floppy 18 guidewire was used to cross the lesion, and an intravascular ultrasound (ivus) was performed prior to the use of the saberx radianz pta balloon catheter.Additional information was requested but was not provided.The device was discarded and will not be returned.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 mild calcification and tortuosity likely contributed to the rupture 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.¿ the information available does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• 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 ; 7863138372
• MDR Report Key: 19962385
• Report Number: 3007635982-2024-00205
• Device Sequence Number: 12944430
• Product Code: LIT
• UDI-Device Identifier: 20705032081754
• UDI-Public: (01)20705032081754(17)260331(10)82276210
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/28/2024

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: 03/31/2026
• Device Catalogue Number: R51006004L
• Device Lot Number: 82276210
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2023
• 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: BRITE TIP RADIANZ CSI.; SABERX RADIANZ PTA BALLOON CATHETER.; SMART-RADIANZ SES.; UNKNOWN IVUS DEVICE.; VASSALLO FLOPPY 18 GUIDEWIRE.
• Patient Sex: Unknown