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

Catalog Number	48002530X
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the surgeon chose a 2.5-300mm saber percutaneous transluminal angioplasty (pta) balloon for dilation.Upon opening the outer packaging, it was found that the sterile packaging bag was already open.Therefore, a new 2.5 balloon was used for the surgery.There was no reported injury to the patient.Additional information and device return was requested; however, neither were obtained after multiple attempts made.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
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, the surgeon chose a 2.5-300 mm saber percutaneous transluminal angioplasty (pta) balloon for dilation.Upon opening the outer packaging, it was found that the sterile packaging bag was already open.Therefore, a new 2.5 balloon was used for the surgery.There was no reported injury to the patient.Additional information was requested; however, the information was not obtained after multiple attempts.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the surgeon chose a 2.5-300mm saber percutaneous transluminal angioplasty (pta) balloon for dilation.Upon opening the outer packaging, it was found that the sterile packaging bag was already open.Therefore, a new 2.5 balloon was used for the surgery.There was no reported injury to the patient.Additional information was requested; however, the information was not obtained after multiple attempts.The device and packaging were returned for evaluation.A non-sterile ¿saber 2.5mm30cm 150¿ device was received coiled inside a clear plastic bag, along with its outer box.The device was unpacked for product evaluation.A thorough visual inspection revealed no damage or anomalies to the device.The outer box was also inspected and showed no signs of damage; however, it was received in an open state.Inside the box, the pouch containing the plastic tray and protective tube was found.The plastic tray was intact with no signs of damage.The pouch exhibited no signs of fraying, splitting, or tearing.However, the side of the pouch that is typically sealed during manufacturing was open, and the seal was missing.No additional irregularities were observed.The open side of the pouch was examined using a vision system, which confirmed that there was no visible evidence to indicate the pouch had ever been sealed.A product history record (phr) review of lot 82320138 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The ¿packaging/pouch/box compromised sterility - seal open¿ was observed during analysis of the returned device and packaging.However, the exact cause cannot be determined.According to microscopic analysis of the returned packaging, no seal pattern markings were present on the portion of the pouch as expected.Therefore, it appears the reported event is related to the manufacturing process and the supplier was notified.According to the warnings in the instructions for use which is not intended to mitigate risk, ¿this product is designed and intended for single use.It is not designed to undergo reprocessing and re-sterilization after initial use.Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.Do not use if inner package is opened or damaged.¿ the reported condition appears potentially related to manufacturing.Based on the current assessment and available data, escalation is not warranted at this time.The issue will continue to be monitored through routine trending and surveillance activities.The supplier has been notified accordingly.
Event or Problem Description
As reported, the surgeon chose a 2.5-300mm saber percutaneous transluminal angioplasty (pta) balloon for dilation.Upon opening the outer packaging, it was found that the sterile packaging bag was already open.Therefore, a new 2.5 balloon was used for the surgery.There was no reported injury to the patient.Additional information was requested; however, the information was not obtained after multiple attempts.The device will 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: 22087523
• Report Number: 3007635982-2025-00113
• Device Sequence Number: 20559493
• Product Code: LIT
• UDI-Device Identifier: 20705032069295
• UDI-Public: (01)20705032069295(17)270831(10)82320138
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2025

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 Catalogue Number: 48002530X
• Device Lot Number: 82320138
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/30/2025; 07/08/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/24/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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: GUIDEWIRE, CATHETER.; OCCLUDER.; PUNCTURE SHEATH.
• Patient Sex: Unknown