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	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An inferior vena cava filter (ivcf) removal procedure commenced to remove a trapease permanent ivcf due to symptomatic ivc occlusions.A philips 16f cavaclear laser sheath was used to treat the patient.During use, a split in the outer jacket with visible fibers was observed, just distal to the bifurcate handle.A new 16f cavaclear was used to complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
A4): patient weight unknown.A5): patient ethnicity unknown.A6): patient race unknown.B6/b7): patient information regarding relevant tests/laboratory data or medical history are unknown.D4): device serial number unknown.G4): 510k/pms number is not applicable.De novo number: den210024.H3/h6): the cavaclear was not returned, thus no returned 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.

• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 19923980
• Report Number: 3007284006-2024-00161
• Device Sequence Number: 20856691
• Product Code: QRJ
• UDI-Device Identifier: 00813132022976
• UDI-Public: (01)00813132022976(11)240119(17)260119(10)F7P24A19A
• 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): 08/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2026
• Device Model Number: 500-516
• Device Catalogue Number: 500-516
• Device Lot Number: F7P24A19A
• 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: 07/19/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2024
• 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: .CORDIS TRAPEASE PERMANENT VENA CAVA FILTER; 0.035 GLIDE GUIDE WIRE, MANUFACTURER UNK.; COOK MEDICAL 18F INTRODUCER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Age: 67 YR
• Patient Sex: Male