MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 16F 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	10/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An inferior vena cava filter (ivcf) removal commenced because the patient no longer needed the ivcf.It was noted that struts of the ivcf had previously perforated and were located outside the ivc.Once the filter had been removed using a spectranetics cavaclear laser sheath, the patient's blood pressure dropped.A covered stent was used to seal off an ivc perforation and 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.
Additional Manufacturer Narrative
510k/pma number is not applicable.De novo number: den210014.The device was discarded, thus no investigation could be completed.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.

• Brand Name: SPECTRANETICS 16F CAVACLEAR LASER SHEATH
• Common Device Name: LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15835621
• Report Number: 1721279-2022-00203
• Device Sequence Number: 5391248
• Product Code: QRJ
• UDI-Device Identifier: 00813132022976
• UDI-Public: (01)00813132022976(11)220715(17)240715(10)F7P22G15A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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 Expiration Date: 07/15/2024
• Device Model Number: 500-516
• Device Catalogue Number: 500-516
• Device Lot Number: FP22G15A
• Was Device Available for Evaluation?: No
• 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: 10/28/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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: CORDIS OPTEASE RETRIEVABLE IVC FILTER.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 45 YR
• Patient Sex: Male