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

Model Number	420-159
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth not available.Patient age not available.Patient sex not available.Due to the covid-19 crisis, there may be a significant delay in return of the device to the manufacturer for evaluation.
Event or Problem Description
A peripheral vascular intervention case commenced.The physician was using a spectranetics turbo elite laser atherectomy catheter from a contralateral approach.He had gained access through the superficial femoral artery (sfa) to target a calcified lesion.During the procedure, while trying to cross the lesion, it was reported that the turbo elite device broke while in use in the patient, treating heavily calcified vessels.There was no reported patient injury.It has been reported that the device is being returned to the manufacturer for evaluation; however this may be delayed due to the covid-19 crisis.This event is being reported at this time due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation, according to the report the manufacturer has been given.
Additional Manufacturer Narrative
The rep for the account informed the manufacturer on 01 may 2020 that the device was discarded and is no longer available to return for evaluation.Method, results, and conclusions codes now populated to reflect this information.

• 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: 9901346
• Report Number: 1721279-2020-00075
• Device Sequence Number: 19416608
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)220121(10)FBH20A13A
• 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): 03/04/2020
• 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: 01/21/2022
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH20A13A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 64
• Date Report Sent to FDA: 01/01/2005