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

Model Number 410-152

Device Problem Material Separation (1562)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

H3): visual inspection found a kink on the working length, approximately 110 cm from the distal tip, with epoxy ablation and charring noted (indicative of heavy use).On the working length, a breach to the outer jacket was observed, with charred and exposed fibers.During functional testing, an 0.014" laboratory guide wire advanced, loading from both the proximal and distal ends, with minimal resistance.H6): based on the device evaluation and investigation, the reported failure (wire could not be advanced over the laser catheter) could not be replicated.The cause of the breach and the exposed fibers could not be established.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 peripheral atherectomy procedure commenced to treat a moderately calcified plaque lesion in the proximal popliteal artery.A spectranetics turbo elite laser atherectomy catheter was used to treat the patient.During use, it was reported that the guide wire could not be advanced over the laser catheter.The device was removed and a new laser catheter was used to complete the procedure with no reported patient harm.However, upon return of the device for evaluation, a breach in the outer jacket was discovered, with exposed fibers in the area.This event is being reported for unintended radiation exposure, potential for harm.

• 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: 17558179
• MDR Text Key: 321457436
• Report Number: 3007284006-2023-00016
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)250214(10)FBD23B02A
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD23B02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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: RUNTHROUGH 0.014 300 CM GUIDE WIRE MFR UNK.; SECOND LASER CATHETER MANUFACTURER/SIZE UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; TERUMO 5F DESTINATION INTRODUCER SHEATH.
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Hispanic
• Patient Race: White