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

Catalog Number	47525150M
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
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 150.014 saberx percutaneous transluminal angioplasty (pta) balloon was used and dilated at 16 atm.However, it ruptured on the first inflation.There was difficulty advancing the balloon catheter through the vessel and while crossing the lesion.A non-cordis 2.5 mm x 150mm balloon was used instead and expanded without issues.The procedure was completed successfully.This occurred in a below the knee case via ipsilateral approach.A non-cordis.014 wire crossed the lesion.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.No kinks or other damages were noted prior to inserting the product into the patient.The device was prepped per the ifu.The device maintained negative pressure during preparation.The intended procedure was evt.The lesion had little calcification.The vessel tortuosity was moderate.The percentage of stenosis was 70%.The device was used for a chronic total occlusion (cto).There was no resistance or friction while inserting the balloon through the rotating hemostatic valve.There was no resistance or friction while inserting the balloon through the guide catheter.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The contrast to saline ratio was 50:50.The device was discarded.
Additional Manufacturer Narrative
As reported, the 2.5 x 150.014 saberx percutaneous transluminal angioplasty (pta) balloon was used and dilated at 16 atm.However, it ruptured on the first inflation.There was difficulty advancing the balloon catheter through the vessel and while crossing the lesion.A non-cordis 2.5 mm x 150mm balloon was used instead and expanded without issues.The procedure was completed successfully.This occurred in a below the knee case via ipsilateral approach.A non-cordis.014 wire crossed the lesion.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.No kinks or other damages were noted prior to inserting the product into the patient.The device was prepped per the ifu.The device maintained negative pressure during preparation.The intended procedure was evt.The lesion had little calcification.The vessel tortuosity was moderate.The percentage of stenosis was 70%.The device was used for a chronic total occlusion (cto).There was no resistance or friction while inserting the balloon through the rotating hemostatic valve.There was no resistance or friction while inserting the balloon through the guide catheter.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The contrast to saline ratio was 50:50.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 2501084490 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint ¿balloon burst at/below rbp and pta/ptca system tracking difficulty¿ could not be evaluated.Without the return of the device, and with no procedural films, the exact cause of the reported event could not be determined.Unspecified procedural, handling, and/or anatomical factors may have contributed to the reported issue.Difficulty tracking through an anatomical structure is a known procedural occurrence.The consequences of tracking difficulty occurring during clinical use of the device are usually addressed by modification in technique or substitution with another device.Tracking difficulty is most commonly related to the patient anatomy, operator technique and appropriate device selection.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 2.5 x 150.014 saberx percutaneous transluminal angioplasty (pta) balloon was used and dilated at 16 atm.However, it ruptured on the first inflation.There was difficulty advancing the balloon catheter through the vessel and while crossing the lesion.A non-cordis 2.5 mm x 150mm balloon was used instead and expanded without issues.The procedure was completed successfully.This occurred in a below the knee case via ipsilateral approach.A non-cordis.014 wire crossed the lesion.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.No kinks or other damages were noted prior to inserting the product into the patient.The device was prepped per the ifu.The device maintained negative pressure during preparation.The intended procedure was evt.The lesion had little calcification.The vessel tortuosity was moderate.The percentage of stenosis was 70%.The device was used for a chronic total occlusion (cto).There was no resistance or friction while inserting the balloon through the rotating hemostatic valve.There was no resistance or friction while inserting the balloon through the guide catheter.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The contrast to saline ratio was 50:50.The device was discarded.

• Brand Name: SABERX014
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 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: 22667058
• Report Number: 1016427-2025-00059
• Device Sequence Number: 3716636
• Product Code: LIT
• UDI-Device Identifier: 20705032089927
• UDI-Public: (01)20705032089927(17)280229(10)2501084490
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 47525150M
• Device Lot Number: 2501084490
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CROSSLEAD TRACKER 0.014.; RAPID CROSS 2.5 MM X 150.
• Patient Sex: Unknown