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

Model Number 414-151

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 04/29/2022

Event Type  malfunction  

Event Description

A peripheral atherectomy procedure commenced to treat a moderately calcified plaque lesion in the patient''s distal posterior tibial (pt) artery.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.During the procedure, the turbo elite''s outer jacket became compromised during advancement across the lesion, and laser light could be observed coming out of the side of the catheter.Use of the turbo elite was discontinued, and another one was opened to complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.

Manufacturer Narrative

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

Manufacturer Narrative

B5): this event is no longer reportable after device evaluation and investigation completed.D9): the device was returned to the manufacturer on 17 may 2022.G3): the device evaluation and investigation were completed on 19 may 2022.H3): the device was returned and evaluated by a cross functional team.The tail tube and working length were in good working condition; no light or breaches were observed throughout the entire outer jacket.A small wrinkle was seen 79 cm from the turbo elite''s distal tip.Although it was reported that red light was observed approximately 6-8 inches from the proximal coupler, there were no dead fibers at the proximal coupler nor at the distal tip, confirming there were no broken fibers within the device.H6): hecc code corrected to 4582 (from 4565 on the initial mdr).Investigation conclusions code 67 remains appropriate for this event.The reported complaint could not be confirmed.There was no unintended radiation exposure; the event is no longer reportable.

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: 14366115
• MDR Text Key: 299951630
• Report Number: 1721279-2022-00096
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)230628(10)FAY21F10A
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY21F10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• 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 ROADRUNNER 0.014 GUIDE WIRE; SECOND SPECTRANETICS TURBO ELITE LASER CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO CM 6F INTRODUCER SHEATH