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

Catalog Number	48002015X
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
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 for a 2mm x 15cm saber percutaneous transluminal angioplasty (pta) balloon catheter could not be deflated.The balloon was not deflated prior to removal and was finally removed by violent yanking.A non-cordis balloon was used as a replacement.There were no reported injuries to the patient.The target vessel was below-the-knee.The target site vessel characteristics included no calcification, no tortuosity, and 30% stenosis.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components.The device maintained negative pressure during preparation.The balloon was inflated to 8 atmospheres.The device will 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 for a 2mm x 15cm saber percutaneous transluminal angioplasty (pta) balloon catheter could not be deflated.The balloon was not deflated prior to removal and was finally removed by violent yanking.A non-cordis balloon was used as a replacement.There were no reported injuries to the patient.The target vessel was below-the-knee.The target site vessel characteristics included no calcification, no tortuosity, and 30% stenosis.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components.The device maintained negative pressure during preparation.The balloon was inflated to eight atmospheres.The device was returned for analysis.A non-sterile unit of ¿saber 2mm15cm 150¿ was received coiled inside of a clear plastic bag.The device was removed from the packaging to proceed with the product evaluation.The unit was inspected observing two kinks located approximately on 30 and 54 cm from the distal tip.The balloon was received deflated.Functional testing was performed, an inflator/deflator device was attached to the inflation port and positive pressure was applied with the purpose of reaching the rated burst pressure.The balloon was inflated and deflated as expected, showing no problems related to the conditions reported.No other outstanding details were observed, and the balloon does not present any inflation or deflation difficulty.The reported ¿balloon deflation difficulty unable¿ was not confirmed through analysis of the returned device.The exact cause cannot be determined.The device passed functional analysis as the balloon was inflated/deflated with no burst or leaks noted and without any issues noted to the balloon.Several kinks were found on the returned device; however, these findings did not interfere with functional analysis.Based on the information provided the device was induced to events that may have contributed to the kinks noted.Due to the nature of the event, the ¿balloon withdrawal difficulty from vessel¿ cannot be confirmed as this cannot be replicated in a lab setting.Various procedural factors and use of concomitant devices can contribute to withdrawal difficulties.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.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.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.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 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: 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: 20865559
• Report Number: 3007635982-2024-00281
• Device Sequence Number: 12902787
• Product Code: LIT
• UDI-Device Identifier: 20705032069202
• UDI-Public: (01)20705032069202(17)260731(10)82292405
• 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): 01/21/2025

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: 07/31/2026
• Device Catalogue Number: 48002015X
• Device Lot Number: 82292405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2024
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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: APT CATHETER.; BD UV18 BALLOON CATHETER.
• Patient Sex: Unknown