MAUDE Adverse Event Report: CORDIS US CORP SABER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	48006015X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the physician was using a 6mm 15cm.018 saber percutaneous transluminal angioplasty (pta) balloon.After his 4th inflation in the patient's right leg (cfa/sfa) the balloon had developed a small leak.This was discovered when the balloon was deflated and slightly bloody saline came back into the inflation device that we being used.The same device was used to complete the procedure.After blood was observed in the inflation device, the balloon was removed and the procedure concluded successfully, with the patient remaining stable.The product was stored properly according to the instructions for use (ifu).No difficulties noted during removal from the hoop, protective balloon cover, stylet, or other sterile packaging components.No kinks or damages were observed prior to insertion, and the device was prepped correctly, maintaining negative pressure.The intended procedure targeted the common femoral artery (cfa), superficial femoral artery (sfa), and popliteal artery (pop).No resistance or friction was noted during insertion through the rotating hemostatic valve.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the physician was using a 6mm 15cm.018 saber percutaneous transluminal angioplasty (pta) balloon.After his 4th inflation in the patient's right leg (cfa/sfa) the balloon had developed a small leak.This was discovered when the balloon was deflated and slightly bloody saline came back into the inflation device that we being used.The same device was used to complete the procedure.After blood was observed in the inflation device, the balloon was removed and the procedure concluded successfully, with the patient remaining stable.The product was stored properly according to the instructions for use (ifu).No difficulties noted during removal from the hoop, protective balloon cover, stylet, or other sterile packaging components.No kinks or damages were observed prior to insertion, and the device was prepped correctly, maintaining negative pressure.The intended procedure targeted the common femoral artery (cfa), superficial femoral artery (sfa), and popliteal artery (pop).No resistance or friction was noted during insertion through the rotating hemostatic valve.The device was not returned for analysis.A product history record (phr) review of lot 82340250 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage - during positive pressure¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.It is likely vessel characteristics, although unknown, and/or procedural factors may have contributed to the reported event.Damage to balloon material may have occurred upon inflation at the target site as inflation occurred four times.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 instructions for use, which are not intended to mitigate risk, ¿preparation 1.Attach a 3-way stopcock to the inflation port, which is marked ¿balloon¿.2.Attach a partially filled syringe with heparinized saline to the stopcock, open the stopcock to the balloon and induce negative pressure.3.Hold the syringe and proximal end of the catheter above the distal end of the catheter, and hold the balloon vertically with the balloon tip pointing down.4.While maintaining negative pressure close the stopcock to the inflation port.Remove the syringe and purge the air.5.To ensure air contained in the balloon and inflation lumen is removed, apply negative pressure twice as instructed and repeat steps 2-4.6.Without twisting, slide the forming tube off the balloon.7.Prepare an angioplasty inflation system with a 50% solution of contrast medium in sterile saline or similar solution.8.Purge the air from the inflation device.9.Connect the inflation device to the 3-way stopcock that is connected to the catheter inflation port, open the stopcock to the catheter and slowly fill the inflation lumen and the balloon will slowly fill with diluted contrast medium.¿ 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 physician was using a 6mm 15cm.018 saber percutaneous transluminal angioplasty (pta) balloon.After his 4th inflation in the patient's right leg (cfa/sfa) the balloon had developed a small leak.This was discovered when the balloon was deflated and slightly bloody saline came back into the inflation device that we being used.The same device was used to complete the procedure.After blood was observed in the inflation device, the balloon was removed and the procedure concluded successfully, with the patient remaining stable.The product was stored properly according to the instructions for use (ifu).No difficulties noted during removal from the hoop, protective balloon cover, stylet, or other sterile packaging components.No kinks or damages were observed prior to insertion, and the device was prepped correctly, maintaining negative pressure.The intended procedure targeted the common femoral artery (cfa), superficial femoral artery (sfa), and popliteal artery (pop).No resistance or friction was noted during insertion through the rotating hemostatic valve.The device will not be returned for evaluation.

• Brand Name: SABER
• 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: 24431573
• Report Number: 3007635982-2026-00034
• Device Sequence Number: 10227573
• Product Code: LIT
• UDI-Device Identifier: 20705032069622
• UDI-Public: (01)20705032069622(17)280531(10)82340250
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2026

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 Catalogue Number: 48006015X
• Device Lot Number: 82340250
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• 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: UNKNOWN.
• Patient Sex: Unknown