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

Model Number	N/A
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a saber 8mmx10cm 90 percutaneous transluminal angioplasty (pta) balloon catheter broke off in the arm and the doctor had to open the arm to remove the device.The device maintained negative pressure during preparation and was not subjected to an acute bend during the procedure.It crossed the lesion easily without kinking or anomalies during delivery.However, during a second inflation at 10¿12 atmospheres (atm) within a stented segment, the balloon ruptured and could not be retracted easily.The device completely separated.A second sheath was inserted and the wire was snared to prevent migration.A surgical cutdown was performed at the initial sheath entry site, the initial sheath was removed and the separated components were retrieved from the lumen, including the wire.The device was not removed intact.The balloon and markers separated from the inner hypotube, which also detached from the catheter shaft.A surgical cutdown was confirmed as necessary for removal.The balloon was not caught in the lesion but was probably caught in a previously deployed non-cordis stent graft placed on (b)(6) 2012.There was no difficulty removing the protective balloon cover or any sterile packaging components.A contralateral approach was not used.The target vessel exhibited 50¿60% stenosis without calcification, tortuosity, acute angles, or bifurcation.The access vessel was a forearm loop graft that was diffusely calcified and exhibited diffuse 30¿40% stenosis with standard looping, but no bifurcation.The device will be returned for analysis.
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.As reported, a saber 8mmx10cm 90 percutaneous transluminal angioplasty (pta) balloon catheter broke off in the arm and the doctor had to open the arm to remove the device.The device maintained negative pressure during preparation and was not subjected to an acute bend during the procedure.It crossed the lesion easily without kinking or anomalies during delivery.However, during a second inflation at 10¿12 atmospheres (atm) within a stented segment, the balloon ruptured and could not be retracted easily.The device completely separated.A second sheath was inserted and the wire was snared to prevent migration.A surgical cutdown was performed at the initial sheath entry site, the initial sheath was removed, and the separated components were retrieved from the lumen, including the wire.The device was not removed intact.The balloon and markers separated from the inner hypotube, which also detached from the catheter shaft.A surgical cutdown was confirmed as necessary for removal.The balloon was not caught in the lesion but was probably caught in a previously deployed non-cordis stent graft placed in september 2012.There was no difficulty removing the protective balloon cover or any sterile packaging components.A contralateral approach was not used.The target vessel exhibited 50¿60% stenosis without calcification, tortuosity, acute angles, or bifurcation.The access vessel was a forearm loop graft that was diffusely calcified and exhibited diffuse 30¿40% stenosis with standard looping, but no bifurcation.The device was returned for analysis.A non-sterile ¿saber 8mm10cm 90¿ was received coiled inside a clear plastic bag.The device was removed from the pouch for the purpose of product evaluation.Upon inspection, the balloon and guidewire lumen were found to be separated.The pta catheter was returned inserted into a cordis csi french 5 sw radial sheath; however, the separated component was not returned for analysis.Additionally, a cordis csi french 8 avanti sheath containing an unidentified device was included in the plastic bag.No damage was observed on either cordis csi sheath, and no other notable findings were identified.The separation site was examined using a vision system and demonstrated irregular features, including elongation, fatigue lines, scratches, and uneven edges.These characteristics are commonly associated with material failure due to tensile overload.Based on these observations, it is presumed that the device was subjected to a tensile force exceeding the material¿s yield strength prior to separation.Functional analysis could not be performed due to the condition of the device as received.The reported ¿balloon separated¿ and ¿balloon burst at/below rbp¿ were observed on the returned device during analysis.The reported ¿balloon withdrawal difficulty snagged/caught on stent¿ could not be directly verified, as this condition cannot be replicated in a laboratory setting; however, the condition of the device as received is consistent with likely balloon entanglement with a stent graft.The device was returned inserted within a cordis csi sheath, which showed no anomalies, and the catheter was removed from the sheath without resistance.Based on the event description and product evaluation findings, the reported failures are most consistent with procedural and handling factors along with tensile overload during attempted withdrawal following balloon rupture.The withdrawal forces applied to overcome this resistance may have exceeded the material yield strength, resulting in tensile overload and complete separation of the balloon, markers, and hypotube from the catheter shaft.Functional testing could not be performed due to the condition of the device as received, limiting further assessment.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.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.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.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Apply negative pressures to the balloon for about 30 - 85 seconds until the balloon is deflated.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.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.¿ based on the available information and product evaluation, there is no evidence to suggest that the reported event was related to a design or manufacturing deficiency.As such, no corrective or preventive action is warranted at this time.

• Brand Name: SABER
• 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 ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 23627670
• Report Number: 3007635982-2025-00243
• Device Sequence Number: 18714995
• Product Code: LIT
• UDI-Device Identifier: 20705032068878
• UDI-Public: (01)20705032068878(17)261231(10)82303858
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 48008010S
• Device Lot Number: 82303858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/23/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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: SABER .018 PTA (48008010S).; VIABAHN STENT GRAFT.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White