MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION CAVACLEAR LASER SHEATH; LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL

Model Number	500-516
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.D4) device serial number unknown.G4) 510k/pms number is not applicable.De novo number: den210024.H3/h6) the cavaclear was discarded, thus no product investigation was performed and the cause of the reported failure could not be established.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
An inferior vena cava filter (ivcf) procedure commenced to remove a cordis optease optional ivcf due to no longer indicated.A philips 16f cavaclear laser sheath was used to treat the patient.During use, when the cavaclear was being rocked back and forth to the filter, it was noticed that the distal tip frayed, exposing the fibers (mdr #3007284006-2025-00239).A second 16f cavaclear was utilized; however, the same malfunction occurred (mdr #3007284006-2025-00240).Then, a third 16f cavaclear was used, and experienced the same issue (mdr #3007284006-2025-00241).The procedure was completed manually with forceps, with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.

• Brand Name: CAVACLEAR LASER SHEATH
• Common Device Name: LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 23569124
• Report Number: 3007284006-2025-00240
• Device Sequence Number: 21364522
• Product Code: QRJ
• UDI-Device Identifier: 00813132022976
• UDI-Public: (01)00813132022976(11)250402(17)270402(10)0303448426
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: 500-516
• Device Catalogue Number: 500-516
• Device Lot Number: 0303448426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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: ANGIODYNAMICS SOS OMNI GUIDE CATHETER (SIZE UNK); GORE MEDICAL 18X33 DRYSEAL INTRODUCER SHEATH; HORIZON MEDICAL 0.35 BENSON GUIDEWIRE; PHILIPS LASER SYSTEM
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White