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

Catalog Number	R51010004L
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 10mm x 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter was stuck on an implanted smart self-expanding stent (ses) and was unable to cross an iliac artery lesion.Additionally, there was difficulty removing the device; however, the device was removed slowly from the patient and the procedure was completed.A vassallo guidewire was used with the saberx radianz pta balloon catheter during this procedure and there was no resistance between the saberx radianz pta balloon catheter and the guidewire.The device was stored and prepped per the instructions for use (ifu) and there was no difficulty removing any of the sterile packaging components.The device was able to maintain negative pressure during preparation.The device was not returned for evaluation.A product history record (phr) review of lot 82271161 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta system - tracking difficulty - through stent¿ and ¿pta system - withdrawal difficulty - through previously deployed stent¿ could not be confirmed as the device nor concomitant devices were returned for analysis.The exact cause cannot be determined.Difficulty crossing a lesion, or an anatomical structure and/or stent is a known procedural occurrence.Crossing difficulty is most commonly related to patient anatomy, operator technique and appropriate device selection.However, without the return of the device for analysis and due to the nature of the complaint it is difficult to draw a clinical conclusion between the device and the event reported.According to the instructions for use, which is not intended as a mitigation of risk, ¿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.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of resistance before proceeding.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.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.H3 other text : device not returned for evaluation.
Event or Problem Description
As reported, a 10mm x 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheter was stuck on an implanted smart self-expanding stent (ses) and was unable to cross an iliac artery lesion.Additionally, there was difficulty removing the device; however, the device was removed slowly from the patient and the procedure was completed.A vassallo guidewire was used with the saberx radianz pta balloon catheter during this procedure and there was no resistance between the saberx radian pta balloon catheter and the guidewire.The device was stored and prepped per the instructions for use (ifu) and there was no difficulty removing any of the sterile packaging components.The device was able to maintain negative pressure during preparation.The device will not be returned for evaluation.

• Brand Name: SABERX RADIANZ
• 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 CR 2 -01 0 ; CS CR 2 01 02 ; 7863138372
• MDR Report Key: 18799376
• Report Number: 3007635982-2024-00048
• Device Sequence Number: 7189467
• Product Code: LIT
• UDI-Device Identifier: 20705032086735
• UDI-Public: (01)20705032086735(17)251231(10)82271161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2024

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 Catalogue Number: R51010004L
• Device Lot Number: 82271161
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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: SMART STENT; VASSALLO GUIDEWIRE
• Patient Sex: Unknown