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

Catalog Number	47512015M
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 1.25mm x 15mm saberx.014 percutaneous transluminal angioplasty (pta) balloon catheter ruptured 6 atmospheres (atm) during its first inflation.When attempting to remove the device from the vessel, the device was stuck and the balloon portion stretched making removal impossible.The luer hub of the saberx pta balloon catheter was removed and a 5f non-cordis catheter was placed over the saberx pta balloon catheter, and both devices were successfully removed together.After removal of the saberx.014 balloon catheter, a non-cordis balloon catheter was used to perform plain old balloon angioplasty (poba), and the procedure was completed.The saberx balloon catheter was being used for pre-dilation of an anterior tibial artery (ata) occlusion with severe calcification, no tortuosity and 100% stenosis.The lesion was access via an ipsilateral antegrade puncture.The device was stored and prepped according to the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components.The balloon maintained negative pressure during preparation.The contrast to saline ratio was 50%.The device will not be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, the balloon of a 1.25mm x 15mm saberx.014 percutaneous transluminal angioplasty (pta) balloon catheter ruptured 6 atmospheres (atm) during its first inflation.When attempting to remove the device from the vessel, the device was stuck and the balloon portion stretched making removal impossible.The luer hub of the saberx pta balloon catheter was removed and a 5f non-cordis catheter was placed over the saberx pta balloon catheter, and both devices were successfully removed together.After removal of the saberx.014 balloon catheter, a non-cordis balloon catheter was used to perform plain old balloon angioplasty (poba), and the procedure was completed.The saberx balloon catheter was being used for pre-dilation of an anterior tibial artery (ata) occlusion with severe calcification, no tortuosity and 100% stenosis.The lesion was access via an ipsilateral antegrade puncture.The device was stored and prepped according to the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components.The balloon maintained negative pressure during preparation.The contrast to saline ratio was 50%.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 2501084475 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, balloon withdrawal difficulty, and pta/ptca system unraveled/stretched¿ 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.Once the balloon burst, it is possible that it caused difficulty in removal of the catheter, and subsequently the stretching of the balloon as it was attempted to forcefully be removed.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.

• 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 ; 7863138372
• MDR Report Key: 22871904
• Report Number: 1016427-2025-00069
• Device Sequence Number: 12184848
• Product Code: LIT
• UDI-Device Identifier: 20705032089811
• UDI-Public: (01)20705032089811(17)280229(10)2501084475
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 47512015M
• Device Lot Number: 2501084475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/10/2025
• 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: 5F GUIDE PLUS.; BASALO SP, 300 CM.; NON-CORDIS BALLOON CATHETER.; PARENT PLUS 45, 53 CM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown