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

Catalog Number	48006006R
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
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, a 6 mm x 60 mm saber.035 percutaneous transluminal angioplasty (pta) balloon catheter was opened and used for pta in the right external artery at 10 atmospheres (atm) for 30 seconds.A non-cordis stent was placed and the same 6 mm x 60 mm saber.035 pta balloon catheter was used to post dilate the stent in the left superficial femoral artery (sfa) at 12 atm for 15 seconds when a balloon rupture occurred.When the balloon catheter was removed from the patient, the balloon was not intact.Half of the balloon and the entire delivery shaft that runs through the balloon portion was left in the patient.The separated balloon was snared, and one radiopaque balloon marker was able to be snared into an unknown sheath.However, the other radiopaque balloon marker was left in the right common femoral artery and was unable to be retrieved.No additional intervention was performed after attempts to snare the separated segment.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components.The contrast to saline ratio was 60% saline and 40% contrast.The target vessel was severely calcified, not tortuous, and had a stenosis percentage of 30-40%.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.This received image has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.
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, a 6mm x 60mm saber.035 percutaneous transluminal angioplasty (pta) balloon catheter was opened and used for pta in the right external artery at 10 atmospheres (atm) for 30 seconds.A non-cordis stent was placed and the same 6mm x 60mm saber.035 pta balloon catheter was used to post dilate the stent in the left superficial femoral artery (sfa) at 12atm for 15 seconds when a balloon rupture occurred.When the balloon catheter was removed from the patient, the balloon was not intact.Half of the balloon and the entire delivery shaft that runs through the balloon portion were left in the patient.The separated balloon was snared, and one radiopaque balloon marker was able to be snared into an unknown sheath.However, the other radiopaque balloon marker was left in the right common femoral artery and was unable to be retrieved.No additional intervention was performed after attempts to snare the separated segment.The contrast to saline ratio was 60% saline and 40% contrast.The target vessel was severely calcified, not tortuous, and had a stenosis percentage of 30-40%.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components.The device was returned for analysis.A non-sterile ¿saber.035 6x60 135cm sl¿ was received coiled inside of a clear plastic bag, along with an unknown non-cordis balloon catheter.The product was unpacked for evaluation.The balloon and inner lumen were received separated and were not returned for analysis.No other notable details were observed.Functional analysis could not be performed due to the condition of the device.The area where the balloon separated was inspected using a vision system, which revealed that the edges showed signs of elongation, and the surface had scratch marks.The elongations on the material are typically associated with separations caused by tensile overload.Therefore, it is assumed that the device was subjected to a tensile force that exceeded the material's yield strength before the separation occurred.The reported ¿balloon burst¿ and ¿balloon separated¿ were evident as the device was received with only a portion of the balloon material attached, the remaining distal portion and inner lumen were not returned for analysis.The exact cause of the events cannot be conclusively determined.Analysis revealed elongations and scratches on the borders of the separated balloon material suggesting the material deformation occurred due to high stressors prior to the rupture/separation.Vessel characteristics, such as the severe calcification reported, may have been a contributing factor, as well as other unspecified procedural/handling factors.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.¿ according to the safety information of the instructions for use ¿if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit.¿ the information available and device analysis do 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: 21559482
• Report Number: 3007635982-2025-00056
• Device Sequence Number: 11855458
• Product Code: LIT
• UDI-Device Identifier: 20705032080863
• UDI-Public: (01)20705032080863(17)270531(10)82314040
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2025

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: 48006006R
• Device Lot Number: 82314040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 04/22/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/04/2025; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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: MEDTRONIC STENT VISI-PRO 035 08MM X 57MM X 135CM.; UNKNOWN SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 59 KG