MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 16F CAVACLEAR LASER SHEATH; LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL

Model Number 500-516

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Great Vessel Perforation (2152)

Event Date 10/28/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 304039378
• Report Number: 1721279-2022-00203
• Device Sequence Number: 1
• Product Code: QRJ
• UDI-Device Identifier: 00813132022976
• UDI-Public: (01)00813132022976(11)220715(17)240715(10)F7P22G15A
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORDIS OPTEASE RETRIEVABLE IVC FILTER.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 45 YR
• Patient Sex: Male