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

Catalog Number	47530300L
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
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 3.0 x 300.014 saberx percutaneous transluminal angioplasty (pta) balloon rupture during treatment.The balloon ruptured upon initial inflation at approximately 14 to 15 atm.The balloon was removed, and the procedure was completed as planned using a new saber.014 balloon of the same size.There was no adverse event was reported.The physician was treating a chronic total occlusion (cto) in the posterior tibial (pt) artery.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the 3.0 x 300.014 saberx percutaneous transluminal angioplasty (pta) balloon rupture during treatment.The balloon ruptured upon initial inflation at approximately 14 to 15 atm.The balloon was removed, and the procedure was completed as planned using a new saber.014 balloon of the same size.There was no adverse event was reported.The physician was treating a chronic total occlusion (cto) in the posterior tibial (pt) artery.Additional information was requested but not provided.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 2306278359 presented no issues during the manufacturing process that can be related to 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.The reported cto of the pt artery may have contributed to the reported event; it is likely to have caused damage to the balloon material that led to its rupture.However, without return of the product for analysis or films of the event it is difficult to draw a clinical conclusion between the device and the reported event.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.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.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.Based on the device history record review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported, the 3.0 x 300.014 saberx percutaneous transluminal angioplasty (pta) balloon rupture during treatment.The balloon ruptured upon initial inflation at approximately 14 to 15 atm.The balloon was removed, and the procedure was completed as planned using a new saber.014 balloon of the same size.There was no adverse event was reported.The physician was treating a chronic total occlusion (cto) in the posterior tibial (pt) artery.The device will be returned for evaluation.

• Brand Name: SABERX014
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes 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: 21357408
• Report Number: 1016427-2025-00007
• Device Sequence Number: 8434788
• Product Code: LIT
• UDI-Device Identifier: 20705032088722
• UDI-Public: (01)20705032088722(17)260731(10)2306278359
• 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): 03/03/2025

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 47530300L
• Device Lot Number: 2306278359
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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: NON REQUIRED
• Patient Sex: Unknown