MAUDE Adverse Event Report: CORDIS CORPORATION SABER035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	48005004R
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
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 information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 5mm x 40mm 135cm saber.035 percutaneous transluminal angioplasty (pta) balloon catheter ruptured during a peripheral procedure.Additionally, a 6mm x 6cm saber.018 pta balloon catheter was used, but the balloon ruptured in two pieces.The devices were able to be removed easily from the patient.An unknown snaring device was used to retrieve the separated balloon, but it was not successful.Other unknown balloons were used during this procedure.This was during a procedure to treat a left proximal superficial femoral artery (sfa) lesion which was tortuous.The devices were "restored" properly per the instructions for use (ifu) and there were no issues removing the sterile packaging.The devices maintained negative pressure during preparation and were prepped with a 60% contrast and 40% saline mixture.Both devices were inflated to 8 atmospheres (atm).The devices will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received.Complaint conclusion: as reported, the balloon of a 5mm x 40mm 135cm saber.035 percutaneous transluminal angioplasty (pta) balloon catheter ruptured during a peripheral procedure.Additionally, a 6mm x 6cm saber.018 pta balloon catheter was used, but the balloon ruptured in two pieces.The devices were able to be removed easily from the patient.An unknown snaring device was used to retrieve the separated balloon, but it was not successful.Other unknown balloons were used during this procedure.This was during a procedure to treat a left proximal superficial femoral artery (sfa) lesion which was tortuous.The devices were "restored" properly per the instructions for use (ifu) and there were no issues removing the sterile packaging.The devices maintained negative pressure during preparation and were prepped with a 60% contrast and 40% saline mixture.Both devices were inflated to 8 atmospheres (atm).The devices will be returned for evaluation.A non-sterile unit of ¿saber.035 5x40 135cm sl¿ 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 that the balloon presents an axial rupture.No other outstanding details were observed.Functional test was performed.One inflator/deflator device was attached to the inflation port.Balloon inflation test was done applying positive pressure using the inflator/deflator device with the purpose of reach the rate burst pressure.However, inflation pressure is not maintained due to the burst condition observed on the balloon.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 and secondary scratch marks located near the damaged border area.The failure reported by the customer as ¿balloon~burst-at/below rbp¿ was confirmed.A burst condition was observed on the balloon.The exact cause of this condition observed on the balloon could not be conclusively determined during the analysis.Vessel characteristics, such as the tortuosity reported, may have been a contributing factor, as well as other unspecified procedural/handling factors.It seems that the material near the damaged area was affected with a sharp object from the outside of the device.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 on the surface could probably led to the damaged condition found on the received device.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.¿ the information available does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SABER035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 21291813
• Report Number: 3007635982-2025-00019
• Device Sequence Number: 9328139
• Product Code: LIT
• UDI-Device Identifier: 20705032079744
• UDI-Public: (01)20705032079744(17)260430(10)82276505
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 48005004R
• Device Lot Number: 82276505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2025
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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: UNKNOWN BALLOON CATHETERS.; UNKNOWN SNARING DEVICE.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White