MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 14F CAVACLEAR LASER SHEATH; LASER-POWERED INFERIOR VENA CAVA FILTER RETRIEVAL

Model Number	500-514
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k: 510k/pma number is not applicable.De novo number: (b)(4).Device evaluated by mfr: the device was discarded, thus no investigation could be completed.Based on the complaint details, excessive force was applied during use.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.The filter was no longer needed, and removing it would eliminate the need for anticoagulation.The physician chose a spectranetics 14f cavaclear laser sheath to remove the filter.As the cavaclear was being used, excessive push/pull force was applied by the physician.As a result, the area where the device''s bifurcate handle and the working length meet, bent at a 90 degree angle, exposing the fibers.The physician discontinued use of the first cavaclear, obtained a new cavaclear, and the filter was successfully removed with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.

• Brand Name: SPECTRANETICS 14F 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: 15583738
• Report Number: 1721279-2022-00175
• Device Sequence Number: 7975255
• Product Code: QRJ
• UDI-Device Identifier: 00813132022969
• UDI-Public: (01)00813132022969(17)230923(10)C6P21J23A(11)210923
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/11/2022

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: 09/23/2023
• Device Model Number: 500-514
• Device Catalogue Number: 500-514
• Device Lot Number: C6P21J23A
• 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: 09/20/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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 GUNTHER TULIP VENA CAVA FILTER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White