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

Catalog Number	48004004X
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a long crack was found on one side of the 4mm 4cm saber percutaneous transluminal angioplasty (pta) balloon.The procedure was completed using atherectomy.There was no reported injury to the patient.The product was properly stored according to the instructions for use (ifu).There was o damage noted to the packaging and no difficulties encountered during unpacking.There were no issues removing the product from the hoop, the balloon cover, or any sterile components.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, a long crack was found on one side of the 4mm 4cm saber percutaneous transluminal angioplasty (pta) balloon.The procedure was completed using atherectomy.There was no reported injury to the patient.The product was properly stored according to the instructions for use (ifu).There was no damage noted to the packaging and no difficulties encountered during unpacking.There were no issues removing the product from the hoop, the balloon cover, or any sterile components.The device will not be returned for evaluation.A product history record (phr) review of lot 82320151 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft cracked¿ could not be verified as the device was not returned for analysis nor were procedural images provided.The exact causes cannot be conclusively determined.Handling of the device, procedural factors, and/or vessel characteristics may have contributed to the event reported by the customer.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and event reported.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.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 actions will be taken at this time.
Event or Problem Description
As reported, a long crack was found on one side of the 4mm 4cm saber percutaneous transluminal angioplasty (pta) balloon.The procedure was completed using atherectomy.There was no reported injury to the patient.The product was properly stored according to the instructions for use (ifu).There was o damage noted to the packaging and no difficulties encountered during unpacking.There were no issues removing the product from the hoop, the balloon cover, or any sterile components.The device will not be returned for evaluation.
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.
Event or Problem Description
As reported, a long crack was found on one side of the 4mm 4cm saber percutaneous transluminal angioplasty (pta) balloon.The procedure was completed using atherectomy.There was no reported injury to the patient.The product was properly stored according to the instructions for use (ifu).There was o damage noted to the packaging and no difficulties encountered during unpacking.There were no issues removing the product from the hoop, the balloon cover, or any sterile components.The device will not be returned for evaluation.
Additional Manufacturer Narrative
This event is no longer considered reportable.Malfunction code of body/shaft-cracked no longer applies.This event no longer meets the definition of a malfunction that requires submission of a regulatory report.
Event or Problem Description
As reported, a long crack was found on one side of the luer hub on the 4mm 4cm saber percutaneous transluminal angioplasty (pta) balloon.The procedure was completed using atherectomy.There was no reported injury to the patient.The product was properly stored according to the instructions for use (ifu).There was o damage noted to the packaging and no difficulties encountered during unpacking.There were no issues removing the product from the hoop, the balloon cover, or any sterile components.The device will not be returned for evaluation.

• 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: 23656063
• Report Number: 3007635982-2025-00247
• Device Sequence Number: 4825140
• Product Code: LIT
• UDI-Device Identifier: 20705032069448
• UDI-Public: (01)20705032069448(17)270831(10)82320151
• 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,Followup,Followup
• Report Date (Section B): 04/24/2026

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: 48004004X
• Device Lot Number: 82320151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/01/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 02/06/2026; 04/23/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/15/2026; 03/03/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2024
• 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
• Patient Sex: Male