MAUDE Adverse Event Report: CORDIS CORPORATION SABERX014; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	47520300M
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon on a 2mm x 300mm saber.014 percutaneous transluminal angioplasty (pta) balloon catheter burst during inflation to 10 atmospheres (atm).There were no reported injuries to the patient.The target vessel was the right posterior tibial (pt).The target site vessel characteristics included moderate calcification, mild tortuosity, and 90% stenosis.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components.The balloon maintained negative pressure during preparation.The device will be returned for evaluation.
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 balloon on a 2mm x 300mm saber.014 percutaneous transluminal angioplasty (pta) balloon catheter burst during inflation to 10 atmospheres (atm).There were no reported injuries to the patient.The target vessel was the right posterior tibial (pt).The target site vessel characteristics included moderate calcification, mild tortuosity, and 90% stenosis.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components.The balloon maintained negative pressure during preparation.A non-sterile unit of ¿pta, rx, 2.0 x 300, 150cm¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.A thorough inspection was performed observing an axial burst on the balloon.Two kinks were observed on the shaft located approximately 56 and 99 cm from the distal tip.No other outstanding details were observed.Functional testing was not performed due to the condition the unit was received.The balloon was inspected with a vision system observing a rupture on the surface where the water is leaking.The balloon surface presented evidence of a rupture condition with elongations and secondary scratch marks located near the damaged border area.The reported event of ¿balloon burst¿ was observed through analysis of the returned device since an axial burst was noted on the balloon.In addition, two kinks were noted on the shaft.The exact cause of the issue experienced could not be conclusively determined during analysis.Unspecified procedural, handling, and/or anatomical factors may have contributed to the reported issue.However, this type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and elongations on the surface could probably lead to the damaged condition found on the received device.It seems that the material near the damaged area was affected by a sharp object from the outside of the device, such as the calcification of the vessel 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.¿ based on the information available for review, there is no indication to suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.
Event or Problem Description
As reported, the balloon on a 2mm x 300mm saber.014 percutaneous transluminal angioplasty (pta) balloon catheter burst during inflation to 10 atmospheres (atm).There were no reported injuries to the patient.The target vessel was the right posterior tibial (pt).The target site vessel characteristics included moderate calcification, mild tortuosity, and 90% stenosis.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components.The balloon maintained negative pressure during preparation.The device will be returned for evaluation.

• Brand Name: SABERX014
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; east 3rd ring middle; 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: 22706038
• Report Number: 1016427-2025-00064
• Device Sequence Number: 8879125
• Product Code: LIT
• UDI-Device Identifier: 20705032086988
• UDI-Public: (01)20705032086988(17)280229(10)2501084486
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221832
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 47520300M
• Device Lot Number: 2501084486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2025
• 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: SABER 014 2X300 (LOT#2501084486).
• Patient Sex: Unknown