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

Catalog Number	R51006006L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
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, a 6mm x 6cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter was used for pre-dilation, but the balloon ruptured at 8 atmospheres (atm).An unknown 5mm x 6cm balloon catheter was used as a replacement to pre-dilate the lesion.One 8mmx 100mm smart radianz ses delivery system was implanted.There were no reported injuries to the patient.This was during a procedure to treat a 90% stenosis left external iliac artery lesion which had moderate calcification.There was no vessel tortuosity.A 6f non-cordis catheter sheath introducer (csi) was used for access.The device was stored, handled, and prepped per the instructions for use (ifu) and there was no difficulty removing the sterile packaging components.The device was able to maintain negative pressure during preparation.The balloon was prepped with a 2:1 saline to contrast ratio.The device was able to be removed easily from the patient and remained in one piece during its removal.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 6mm x 6cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter was used for pre-dilation, but the balloon ruptured at eight atmospheres (atm).An unknown 5mm x 6cm balloon catheter was used as a replacement to pre-dilate the lesion.One 8mmx 100mm smart radianz ses delivery system was implanted.There were no reported injuries to the patient.This was during a procedure to treat a 90% stenosis left external iliac artery lesion which had moderate calcification.There was no vessel tortuosity.A 6f non-cordis catheter sheath introducer (csi) was used for access.The device was stored, handled, and prepped per the instructions for use (ifu) and there was no difficulty removing the sterile packaging components.The device was able to maintain negative pressure during preparation.The balloon was prepped with a 2:1 saline to contrast ratio.The device was able to be removed easily from the patient and remained in one piece during its removal.The device was not returned for analysis.A product history record (phr) review of lot 82275755 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 and 90% 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.

• Brand Name: SABERX RADIANZ
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 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: 18382648
• Report Number: 3007635982-2023-00353
• Device Sequence Number: 7797289
• Product Code: LIT
• UDI-Device Identifier: 20705032081549
• UDI-Public: (01)20705032081549(17)260131(10)82275755
• 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): 01/08/2024

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: 01/31/2026
• Device Catalogue Number: R51006006L
• Device Lot Number: 82275755
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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: 8MMX 100MM SMART STENT; ANOTHER DEVICE (5MM*6CM); UNKNOWN 6F DESTINATION SHEATH
• Patient Sex: Female