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

Model Number 417-152

Device Problem Material Separation (1562)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 11/27/2023

Event Type  malfunction  

Event Description

A peripheral atherectomy procedure commenced to treat a chronic total occlusion (cto) of a moderately calcified fibrous lesion in the mid superficial femoral artery (sfa).A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.When the procedure was completed and the turbo-elite was removed, the physician noticed the tip of the catheter was charred and discolored.The procedure was completed with no reported patient harm.During device evaluation, the outer jacket was found melted and breached near the distal tip.This event is being reported for unintended radiation exposure, potential for harm.

Manufacturer Narrative

A2): patient''s date of birth, age unk.A3): patient''s gender unk.A4): patient''s weight unk a5a./5b.): patient''s ethnicity/ra.Ce unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.H3): the turbo-elite device was returned for evaluation.Visual inspection found extensive epoxy wear and charred material surrounding the distal tip.The outer jacket was melted and breached, just proximal to the fuse at the distal tip, with no broken fibers identified.No other damage was observed along the working length, bifurcate, or tail tube.It was confirmed that proper flushing technique, in accordance with the ifu, was performed throughout the procedure.H6): based on the device evaluation and completion of the investigation, it has been determined that the patient''s condition/target lesion (cto) caused or contributed to the difficulty of hydration reaching the treatment site.The lack of hydration resulted in the damage noted near the distal tip of 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.

• Brand Name: TURBO-ELITE LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 18489718
• MDR Text Key: 333098024
• Report Number: 3007284006-2024-00004
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)250809(10)FAZ23H02A
• 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
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ23H02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• 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: BOSTON SCIENTIFIC 0.018 GUIDE WIRE; CORDIS BRITE TIP 6F INTRODUCER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM