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

Model Number	417-156
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age and date of birth unavailable.Manufacturer is anticipating the return of the device but the device has not arrived at this time.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a calcified lesion in the distal superficial femoral artery (sfa), popliteal and posterior tibial (pt) arteries.During use of a spectranetics turbo elite laser atherectomy catheter (when the physician removed the device from the patient''s body), it was reported that the catheter had been broken in half; however there was no reported embolus, so no portion of the device was left in the patient.The procedure was completed with use of an ivus catheter and a second device with no reported patient harm.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.The manufacturer is anticipating return of the device for evaluation but the device has not arrived at this time.
Additional Manufacturer Narrative
Device was returned to manufacturer on 17 dec 2019.Device evaluation completed by manufacturer.Method, results and conclusions codes populated after device evaluation completed.Device evaluation: the device was returned and evaluated by a cross functional engineering team on 18 dec 2019.During visual inspection, the team identified damage and a breach to the device''s outer jacket starting the guide wire port of the device and extending distally towards the device tip (longitudinal tear).The inner lumen was also confirmed to have torn at the same location.The outer jacket and inner lumen tore from the inside, outwardly.Only one broken fiber was noticed at the distal tip.The remaining fibers in the device were intact.The damage most likely occurred from removal of the guide wire in the opposite direction of the catheter, causing the tear (breach) to inner lumen and outer jacket.

• 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: 9460275
• Report Number: 1721279-2019-00216
• Device Sequence Number: 14213026
• Product Code: MCW
• UDI-Device Identifier: 00813132024741
• UDI-Public: (01)00813132024741(17)211024(10)FBG19K19A
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 11/20/2019
• 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: 10/24/2021
• Device Model Number: 417-156
• Device Catalogue Number: 417-156
• Device Lot Number: FBG19K19A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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: SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Weight: 70
• Date Report Sent to FDA: 01/01/2005