MAUDE Adverse Event Report: CORDIS US. CORP SABERX014; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	47530040M
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 3mm x 40mm saberx.014 ruptured during the first inflation at six atmospheres (atm).The procedure was completed without issue using an unknown replacement product.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.There was no difficulty removing the protective balloon cover.There was no difficulty removing the 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.The device was used for an endovascular thrombectomy (evt).There was severe vessel calcification without tortuosity and 100% stenosis.There was no resistance or friction while inserting the balloon through the through the rotating hemostatic valve, the guide catheter or advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion with the balloon catheter and the catheter was never in an acute bend.There was no balloon catheter kink during use.The contrast to saline ratio was 2:1.The procedure was completed with a non-cordis balloon catheter.The device was used as the pre-dilation balloon for an external iliac artery chronic total occlusion (eiacto) procedure.The device was not returned for evaluation as it was discarded.A product history record (phr) review of lot: 2304174488 revealed no anomalies or non-conformance's 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 severe calcification and a chronic total occlusion likely contributed to the reported event.Damage to balloon material may have occurred upon crossing or during inflation.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, ¿carefully inspect the catheter prior to use to verify that the catheter has not been damaged and that its size, shape and condition are suitable for the procedure for which it is to be used.Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution via the guide-wire access port prior to use.Never attempt to move the guide wire when the balloon is inflated.Do not advance the catheter against significant resistance.The cause of resistance should be determined via fluoroscopy.Inflation in excess of the rated burst pressure may cause the balloon to rupture.Use the recommended balloon inflation medium (25% contrast medium/75% sterile saline solution).It has been shown that a 25/75% contrast / saline ratio has yielded faster balloon inflation / deflation times.Never use air or other gaseous medium to inflate the balloon.If resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon.If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/ introducer sheath as a single unit.Do not continue to use the balloon catheter if the shaft has been bent or kinked.¿ 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, a 3mm x 40mm saberx.014 ruptured during the first inflation at 6 atmospheres (atm).The procedure was completed without issue using an unknown replacement product.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.There was no difficulty removing the protective balloon cover.There was no difficulty removing the 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.The device was used for an endovascular thrombectomy (evt).There was severe vessel calcification without tortuosity and 100% stenosis.There was no resistance or friction wile inserting the balloon through the through the rotating hemostatic valve, the guide catheter or advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion with the balloon catheter and the catheter was never in an acute bend.There was no balloon catheter kink during use.The contrast to saline ratio was 2:1.The procedure was completed with a non-cordis balloon catheter.The device was used as the pre-dilation balloon for an external iliac artery chronic total occlusion (eiacto) procedure.The device will not be returned as it was discarded.

• Brand Name: SABERX014
• 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 ; 15th building smes venture park songshan lake hi-tech zone; dongguan, guangdong 52380-8 ; CH 523808 ; 7863138372
• MDR Report Key: 24821749
• Report Number: 1016427-2026-00023
• Device Sequence Number: 9594489
• Product Code: LIT
• UDI-Device Identifier: 20705032088777
• UDI-Public: (01)20705032088777(17)260430(10)2304174488
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 47530040M
• Device Lot Number: 2304174488
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2023
• 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: COYOTE 3-40.
• Patient Sex: Unknown