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

Catalog Number	48002504X
Medical Device Problem Codes	Deflation Problem (1149); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
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 4f 2.5 mm x 4 cm 150 cm.018 saber percutaneous transluminal angioplasty (pta) catheter would not deflate after initial inflation.Resistance was met while withdrawing the device because the balloon would not deflate and was stuck on the guidewire.The device separated in the patient at the proximal portion of the balloon junction where it meets the shaft.In an attempt to remove the balloon, the user pulled very hard and the strain relief at the junction where it meets the shaft separated.The physician was able to retrieve the broken pieces.They were able to navigate a second unknown.014¿ wire down next to the balloon to maintain wire access.Attempts were made to pull the device out slowly, but it was determined the balloon was stuck on the original unknown.018¿ guidewire.The unknown interventional sheath was brought down as close as possible to the balloon and then the unknown.018¿ wire, balloon-stuck on the wire, and unknown sheath were all removed together and unknown.014¿ wire access was maintained.The device was opened in a sterile field and stored per product labeling.There was no difficulty removing the protective balloon cover.There was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.The device was not put into an acute bend at any point during the procedure.The device was partially able to cross the lesion.The device did not kink at any time during the procedure.Resistance was met while advancing the device at the lesion and while attempting to cross.Excessive torquing was not required.Resistance was met while advancing the device over the guidewire at the lesion and while attempting to cross.The balloon was caught in the lesion and would not deflate.The balloon was not caught in a deployed stent.The target site was the distal anterior tibial to dorsalis pedis and was heavily calcified with 99% stenosis.An antegrade approach was made.Other procedural details were requested but were not provided.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the balloon of a 4f 2.5 mm x 4 cm 150 cm.018 saber percutaneous transluminal angioplasty (pta) catheter would not deflate after initial inflation.Resistance was met while withdrawing the device because the balloon would not deflate and was stuck on the guidewire.The device separated in the patient at the proximal portion of the balloon junction where it meets the shaft.In an attempt to remove the balloon, the user pulled very hard and the strain relief at the junction where it meets the shaft separated.The physician was able to retrieve the broken pieces.They were able to navigate a second unknown.014¿ wire down next to the balloon to maintain wire access.Attempts were made to pull the device out slowly, but it was determined the balloon was stuck on the original unknown.018¿ guidewire.The unknown interventional sheath was brought down as close as possible to the balloon and then the unknown.018¿ wire, balloon-stuck on the wire, and unknown sheath were all removed together and unknown.014¿ wire access was maintained.The device was opened in a sterile field and stored per product labeling.There was no difficulty removing the protective balloon cover.There was no difficulty removing any of the sterile packaging components.The device maintained negative pressure during preparation.The device was not put into an acute bend at any point during the procedure.The device was partially able to cross the lesion.The device did not kink at any time during the procedure.Resistance was met while advancing the device at the lesion and while attempting to cross.Excessive torquing was not required.Resistance was met while advancing the device over the guidewire at the lesion and while attempting to cross.The balloon was caught in the lesion and would not deflate.The balloon was not caught in a deployed stent.The target site was the distal anterior tibial to dorsalis pedis and was heavily calcified with 99% stenosis.An antegrade approach was made.Other procedural details were requested but were not provided.A non-sterile ¿saber 2.5mm4cm 150¿ was received coiled inside of a clear plastic bag.The device was unpacked to perform the product evaluation.The device was returned in two pieces.One piece is the distal section, separated approximately 15 cm from the distal tip.The other piece is a 159 cm shaft with an unknown 0.018¿ guidewire inserted inside.In the middle of this long segment, a frayed condition on the shaft is observed.Attempts to withdraw the stuck guidewire from the 159 cm shaft were unsuccessful.The proximal section, including the luer hub, was not returned for analysis.The balloon is not separated or burst and the balloon material folded over the distal tip.Functional analysis could not be performed because the unit was received in two pieces without the luer hub and with an unknown guidewire stuck inside the lumen.The separated distal edge of the 159 cm shaft with the unknown 0.018¿ guidewire was evaluated with a vision system.The distal edge inspection revealed elongations in the separated material, commonly associated with separations caused by material tensile overload.The separated proximal edge of the 159 cm shaft with the unknown 0.018¿ guidewire was also evaluated with a vision system.The proximal edge inspection revealed elongations in the separated material, commonly associated with separations caused by material tensile overload.The damage in the middle of the 159 cm shaft segment with the unknown 0.018¿ guidewire inside was evaluated with a vision system.The inspection revealed elongations in the frayed material, commonly associated with fraying caused by material tensile overload.Additionally, the inner lumen presents an accordioned condition.The damage on the proximal edge of the piece with the balloon was evaluated with a vision system.The inspection revealed elongations in the separated material, commonly associated with separations caused by material tensile overload.The piece with the balloon was inspected with a vision system.The balloon material is folded over the distal tip, and no damages were observed on the balloon surface.The reported ¿body/shaft separated¿, ¿guidewire lumen resistance/friction¿ and ¿strain relief separated¿ were observed during analysis of the returned device as it was returned in poor condition and separated in several areas with an unknown guidewire stuck inside the shaft.However, the exact cause cannot be determined of these damages cannot be conclusively determined.Based on the condition of the received device the reported ¿balloon deflation difficulty unable to¿ could not be verified as inflation/deflation testing could not be performed.The analysis provided indicates the device was induced to events that exceeded its yield strength prior to the separations noted.Additionally, the shaft was induced to tensile forces causing elongations and an accordioned condition to the inner lumen trapping the unknown guidewire inside the lumen.Based on the available information, the events reported were influenced by several factors: the vessel's heavy calcification and 99% stenosis, procedural factors, and the handling of the device, including the application of excessive force.According to the safety information of 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.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 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.¿ 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.¿ the information available nor product analysis suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken 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: 21774431
• Report Number: 3007635982-2025-00075
• Device Sequence Number: 8263649
• Product Code: LIT
• UDI-Device Identifier: 20705032069257
• UDI-Public: (01)20705032069257(17)250831(10)82258220
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 48002504X
• Device Lot Number: 82258220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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: SECOND UNKNOWN .014¿ WIRE; UNKNOWN .018¿ GUIDEWIRE; UNKNOWN INTERVENTIONAL SHEATH; UNKNOWN SHEATH
• Patient Age: 69 YR
• Patient Sex: Male