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

Model Number	500-514
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4): patient's weight unk.D4): device serial number unk.G4): 510k/pma number is not applicable.De novo number: den210024.H3): the device was discarded, thus no investigation could be completed.H6): based on the complaint details and philips physician assessment, the device buckled when forward pressure was applied, indicating that excessive force was likely applied during use.The spectranetics ifu states to use gentle pressure on the laser sheath to advance the device.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
A procedure commenced to remove an inferior vena cava (ivc) filter due to the filter no longer indicated.A philips 14f cavaclear laser sheath was used, with an 18f outer sheath, down the external jugular (ej) to attempt filter removal.During the procedure, the outer jacket buckled upon forward pressure near the bifurcate handle, resulting in a breach of the outer jacket.The physician felt heat from the buckled area on his gloved hand, but there was no injury detected.Use of the cavaclear was immediately discontinued, and the procedure was completed with use of endobronchial 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 18248101
• Report Number: 3007284006-2023-00075
• Device Sequence Number: 7108917
• Product Code: QRJ
• UDI-Device Identifier: 00813132022969
• UDI-Public: (01)00813132022969(11)221122(17)241122(10)F6P22L22A
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2023

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: 11/22/2024
• Device Model Number: 500-514
• Device Catalogue Number: 500-514
• Device Lot Number: F6P22L22A
• 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: Not provided
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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: 18F/40CM OUTERSHEATH MANUFACTURER UNK.; IVCF MANUFACTURER/MODEL UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White