MAUDE Adverse Event Report: CORDIS US CORP SABER014; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	47025250M
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
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 2.5 x 250.014 saber percutaneous transluminal coronary angioplasty (ptca) balloon ruptured during the procedure.There was no reported injury to the patient.Additional information and device return was requested; however, neither were obtained after multiple attempts made.
Event or Problem Description
As reported, the 2.5 x 250.014 saber percutaneous transluminal coronary angioplasty (ptca) balloon ruptured during the procedure.There was no reported injury to the patient.Additional information and device return was requested; however, neither were obtained after multiple attempts made.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the 2.5 x 250.014 saber percutaneous transluminal coronary angioplasty (ptca) balloon ruptured during the procedure.There was no reported injury to the patient.Additional information was requested; however, not obtained after multiple attempts made.The device was returned for evaluation.One non-sterile unit of a pta, otw, 2.5 × 250, 150 cm was received inside a clear plastic bag.The device was unpacked to proceed with product evaluation.Upon visual inspection, the device was observed to be coiled, and the balloon was fully deflated.The remaining components of the unit were also inspected, with no abnormalities noted.The inflation/deflation test was performed.During functional testing, the balloon was able to be fully inflated and deflated as intended.The device was inspected for any damage or anomalies that may have contributed to the reported failure, and none were observed on the returned device.A product history record (phr) review of lot 2506199585 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ was not observed through analysis of the returned device.The exact cause of the reported event could not be determined as the device passed functional analysis.The balloon was inflated/deflated with no burst or leaks noted and without any anomalies noted to the balloon.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the event reported by the customer as no anomalies were noted on the device.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.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 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, the 2.5 x 250.014 saber percutaneous transluminal coronary angioplasty (ptca) balloon ruptured during the procedure.There was no reported injury to the patient.Additional information and device return was requested; however, neither were obtained after multiple attempts made.

• Brand Name: SABER014
• 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 ; 7863138372
• MDR Report Key: 24548088
• Report Number: 1016427-2026-00015
• Device Sequence Number: 9404474
• Product Code: LIT
• UDI-Device Identifier: 20705032087640
• UDI-Public: (01)20705032087640(17)280731(10)2506199585
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

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: 47025250M
• Device Lot Number: 2506199585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 04/15/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/04/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2025
• 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