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

Model Number 417-152

Device Problems Material Separation (1562); Material Deformation (2976)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

A peripheral atherectomy procedure commenced to treat a slightly calcified plaque lesion in the mid tibioperoneal (tp) trunk.A spectranetics 1.7 turbo-elite laser atherectomy catheter was used to treat the patient.During use, it was reported that the outer jacket was compromised, with laser light seen exiting the side of the catheter.Use of the turbo-elite was discontinued, and a new catheter was used to complete the case with no reported patient harm.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/race unk b6): relevant tests/laboratory data unk b7): other relevant history unk h3/h6): the device was returned to the manufacturer but the evaluation has not yet begun.A supplemental mdr will be submitted upon completion of the device evaluation and investigation.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 has been determined to no longer be reportable.G3): the device evaluation and investigation was completed on 07dec2023.H3): the turbo-elite was returned for evaluation.Visual inspection found that distal to the bifurcate handle, the outer jacket was damaged (kinked/wrinkled, pinched and stretched, with coating flaking off) along the working length.During functional testing, simulated laser light emitted from under the jacket at 60 cm and 66 cm distal to the bifurcate handle, where a broken fiber was detected in each area.However, there were no breaches to the outer jacket present along the entire working length of the catheter.H6): based on the device evaluation and investigation, the cause of the catheter damage could not be established.Medical device problem code corrected to 2976 (from 1562).Hecc code corrected to 4582 (from 4565).Investigation findings code 3243 added (code 3233 no longer applicable).Investigation conclusions code 4315 added (code 11 no longer applicable).All other codes from the initial mdr remain applicable.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.Device evaluation confirmed there was no breach to the outer jacket of the turbo-elite catheter.

• 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: 18249182
• MDR Text Key: 329508699
• Report Number: 3007284006-2023-00081
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)250614(10)FAZ23F06A
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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: FAZ23F06A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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: COOK MEDICAL 0.018 ROADRUNNER GUIDE WIRE.; COOK MEDICAL 6F INTRODUCER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.