MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 417-152

Device Problem Thermal Decomposition of Device (1071)

Patient Problems Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2022

Event Type  malfunction  

Event Description

A peripheral atherectomy procedure commenced to treat a moderately calcified lesion in the patient's distal superficial femoral artery (sfa).The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.During the procedure, it was reported that the turbo elite would not cross the lesion.Upon removal, it appeared the tip of the catheter had almost collapsed on itself and burned.The procedure was completed with a second catheter.No reported patient harm.This report captures the turbo elite device which was damaged during the procedure, causing unintended radiation exposure, potential for harm.

Manufacturer Narrative

Patient's date of birth unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was not returned to the manufacturer, thus no investigation could be completed.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.

Manufacturer Narrative

B5): this event is no longer reportable after device evaluation and investigation completed.D9): the device was returned to the manufacturer on 08nov2022.G3): the device evaluation and investigation were completed on 10nov2022.H3): the device was evaluated by a cross functional team.Visual inspection found the distal tip was concentric with no melted areas present; the epoxy at the distal tip was in good condition and 2 dead fibers were observed.Excessive biologics were present in the device''s inner lumen.A wrinkle was present 53 cm from the distal tip with broken fibers observed under the jacket in this area, but no breach was observed.During functional testing, when backloading and frontloading a.018" guidewire through the turbo elite, it became stuck 9.5 cm from its distal tip; no external damage was noted in this area.The device calibrated and ran at high energy.The complaint could not be confirmed.H6): based on the device evaluation, there was no breach or melted areas observed in the turbo elite''s outer jacket at the distal tip.Therefore, the hecc code was corrected to 4582 (from 4565 on the initial mdr).Additionally, investigation conclusions code 67 remains appropriate for this event.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

This event is no longer reportable for unintended radiation exposure - potential for harm.Per the returned device analysis, no broken fibers or breach to the outer jacket were observed.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• 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: 15725260
• MDR Text Key: 303022096
• Report Number: 1721279-2022-00188
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170059
• 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,Followup
• Report Date: 11/17/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ22A03A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2022
• 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: 5F INTRODUCER SHEATH MANUFACTURER UNK.; ABBOTT COMMAND 0.014 GUIDE WIRE.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Age: 81 YR
• Patient Sex: Male