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

Catalog Number	48008004X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, the proximal edge of the balloon on an 8mm x 4cm saber percutaneous transluminal angioplasty (pta) balloon catheter was separated out of the box.A separation was also noted to the distal portion of the plastic balloon covering and there was difficulty removing the balloon cover.The device did not enter the patient and was not used.There were no reported injuries to the patient.This was during a pedal access procedure in which a 4f 10cm rain tibial pedal catheter sheath introducer (csi) was used.There was no damage to the outer packaging for the saber pta balloon catheter observed prior to opening the device.The device was stored per the instructions for use (ifu), and there was no difficulty removing it from the packaging.The balloon cover was not rotated or twisted during removal.The device was discarded and was not returned.A product history record (phr) review of lot 82306844 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box - removal difficulty - protective balloon cover (balloon catheters)¿ and "balloon separated" could not be verified as the device was not returned for analysis, nor were procedural images provided.The exact cause of the reported event cannot be determined.Handling and procedural factors likely contributed to the reported event.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.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.Without twisting, slide the forming tube off the balloon.Remove the forming tube from the balloon.¿ 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.
Event or Problem Description
As reported, the proximal edge of the balloon on an 8mm x 4cm saber percutaneous transluminal angioplasty (pta) balloon catheter was separated out of the box.A separation was also noted to the distal portion of the plastic balloon covering and there was difficulty removing the balloon cover.The device did not enter the patient and was not used.There were no reported injuries to the patient.This was during a pedal access procedure in which a 4f 10cm rain tibial pedal catheter sheath introducer (csi) was used.There was no damage to the outer packaging for the saber pta balloon catheter observed prior to opening the device.The device was stored per the instructions for use (ifu), and there was no difficulty removing it from the packaging.The balloon cover was not rotated or twisted during removal.The device was discarded and will not be returned.

• 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 CR 2 -01 0 ; CS CR 2 01 02 ; 7863138372
• MDR Report Key: 24136023
• Report Number: 3007635982-2026-00014
• Device Sequence Number: 20197731
• Product Code: LIT
• UDI-Device Identifier: 20705032069721
• UDI-Public: (01)20705032069721(17)270228(10)82306844
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

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: 48008004X
• Device Lot Number: 82306844
• 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: 12/29/2025
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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: 4F 10CM RAIN TIBIAL PEDAL CSI
• Patient Age: 77 YR
• Patient Sex: Unknown