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

Model Number	410-152
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is anticipating return of the device for evaluation but has not received it at this time.A supplemental mdr will be submitted after the device is returned, and the device evaluation and investigation have been completed.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat the distal segment of a severely calcified lesion in the patient's peroneal artery.A spectranetics turbo elite laser atherectomy catheter was chosen to treat the patient.The patient had a tight chronic total occlusion of this area.In the process of the physician advancing the turbo elite device through this area for the last pass after completing multiple passes through the lesion, the catheter reportedly was compromised.There was light observed flashing out of the device's sheath and there was observable fracture in the same portion from which the light emitted.This area of the turbo elite device was outside the patient's body.There was no reported patient or user harm.The turbo elite device was removed safely from the patient.The case was then successfully completed using a balloon and stent.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
Additional Manufacturer Narrative
D9): device was returned to the manufacturer on 29 june 2021.G3): device was evaluated by a cross functional team on 01 july 2021.H3): device analysis: a kink was seen 16.5cm from the device's bifurcate handle.A breach in the device's outer jacket with exposed and broken fibers was seen in the kinked area.H6): historically, the manufacturer has seen this failure when excessive forces are applied to the side of the outer jacket.The device becomes kinked and then broken fibers at the area of the kink produce laser energy, which creates a breach in the outer jacket.This event has been determined to be use related.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 12062173
• Report Number: 1721279-2021-00117
• Device Sequence Number: 3800791
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)230325(10)FBD21C17A
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2023
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD21C17A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT 4F INTRODUCER SHEATH; COOK MEDICAL 0.014 GUIDE WIRE; COOK MEDICAL CXI .018 150 GUIDE CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Age: 71 YR
• Patient Weight: 76