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

Model Number	414-151
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable from facility.Device evaluation: the device was evaluated on 07 jan 2020 by a cross functional engineering team.The team noted visible damage to the turbo elite device, along with noting a visible kink and broken fibers 64.5cm from the device's distal tip.Using simulated laser light, visible red light was seen under the device's outer jacket.However, there was no breach in the outer jacket, therefore no unintended exposure to radiation.The inner lumen was tested due to a suspected breach in the inner lumen.Using a 20cc syringe filled with water, water entered the device's inner lumen and into the outer jacket of the device.The device's outer jacket was removed to more closely evaluate the inner lumen.With the outer jacket removed, there were visible broken fibers, and a discolored area present in the inner lumen caused from heat from the broken fibers in the area.The inner lumen showed water leaking through device, confirming a breach to the inner lumen of the device.The investigation concluded there was no outer jacket breach in the damaged area, but the device's inner lumen was breached in the damaged area.Due to the breach in the inner lumen, there is a potential of exposure to manufacturing materials from the breach in the inner lumen, although unlikely due to the small size of the inner lumen breach; therefore this report is being submitted for the potential of exposure to manufacturing materials that may have been present within the inner lumen.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a plaque lesion in the right mid peroneal artery.During use of the spectranetics turbo elite device, the physician reported that the device was difficult to advance over the guide wire being used in the procedure.The scrub tech noticed laser light coming from the side of the turbo elite device's working length.The device was removed and a new turbo elite device was used to complete the laser atherectomy without any further issues.The patient was successfully treated with no reported injury.This event is being reported due to the potential for exposure to manufacturing materials.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9564154
• Report Number: 1721279-2020-00002
• Device Sequence Number: 14025167
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)211005(10)FAY19J26A
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2019
• Report Date (Section F): 01/01/2005

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: 10/05/2021
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY19J26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005