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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2) patient's date of birth- not available from facility.A3b) patient's gender- not available from facility.B6) relevant tests/laboratory data- not available from facility.D4) device serial number- not available from facility.G4) 510k/pma number is not applicable.De novo number: den210014.H3) the device was discarded; thus no investigation could be completed.H6) great vessel perforation is a known risk of complication with use of the cavaclear 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
An inferior vena cava (ivc) filter removal commenced because the patient no longer needed the ivc filter.Prior to use of the spectranetics 16f cavaclear laser sheath, other modalities were used to attempt removal, but unsuccessful due to the filter being embedded to the ivc.Then, the cavaclear was advanced and during use, an ivc perforation was detected via angiogram.Therefore, a stent was placed to treat the perforation, while also securing the filter to the vessel wall.The patient survived the procedure.This report captures the cavaclear in use when the ivc perforation occurred, requiring intervention.There was no alleged malfunction of the cavaclear device in use during the procedure.

• 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: 21417198
• Report Number: 3007284006-2025-00034
• Device Sequence Number: 20800997
• Product Code: QRJ
• UDI-Device Identifier: 00813132022976
• UDI-Public: (01)00813132022976(11)241210(17)261210(10)0303360660
• 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): 02/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 500-516
• Device Catalogue Number: 500-516
• Device Lot Number: 0303360660
• 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: 01/28/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2024
• 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: COOK MEDICAL TULIP OPTIONAL IVC FILTER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 135 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White