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 Material Twisted/Bent (2981)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

Patient's date of birth, age: unk.Patient's weight: unk.Patient's ethnicity/race: unk.Relevant tests/laboratory data: unk.Other relevant history: unk.510k/pma number is not applicable.De novo number: (b)(4).The device was discarded, thus no investigation could be completed.Based on the complaint details, it is likely that the user's technique by twisting back and forth caused the break in the working length.Per the ifu, it 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 Description

A procedure commenced to remove an inferior vena cava filter (ivcf) due to caval occlusion, leg swelling, and pain.The physician chose a spectranetics 16f cavaclear laser sheath to remove the filter.When the physician was using the cavaclear, he torqued the device (twisted the device back and forth) in attempt to remove the ivcf.Afterward, he noticed the cavaclear's bifurcate handle felt warmer than normal.Examination of the device revealed a partial separation on the working length, just distal to the bifurcate handle with red light emitting from the area; therefore, the cavaclear was removed from the patient.A new 16f cavaclear was used to successfully remove the ivcf, and the patient survived the procedure.This event is being reported for unintended radiation exposure, potential for harm.

• 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: 15945846
• MDR Text Key: 305181496
• Report Number: 1721279-2022-00225
• Device Sequence Number: 1
• Product Code: QRJ
• UDI-Device Identifier: 00813132022976
• UDI-Public: (01)00813132022976(17)240921(10)F7P22J21A
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-516
• Device Catalogue Number: 500-516
• Device Lot Number: F7P22J21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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 IVC PERMANENT FILTER MODEL UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Male