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

Model Number	410-154
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable from facility.Device evaluation: the turbo elite device was evaluated on 18 april, 2019 by a (b)(4) team.The team confirmed the catheter working length was severely bent, kinked and damaged at 16 cm and 19 cm from the distal tip.A breach in the device's outer jacket was confirmed via microscopic examination.This was determined to be a use issue.
Event or Problem Description
A peripheral procedure commenced to treat a stenosed vessel in a mid to distal superficial femoral artery of mixed morphology and moderate calcification.The physician reportedly successfully crossed the lesion with a wire, and then with a crossing catheter.A spectranetics turbo elite device was then used to treat the lesion.The physician reportedly met resistance while lasing; he was able to cross the lesion, but it was tight.The fluency of the device was increased and another pass was attempted at crossing the lesion again.However, the physician reported that passing the laser "didn't feel right" and removed the device to observe it.The device was reportedly mangled.The physician then used another turbo elite device to complete the procedure successfully with no reported patient harm.When the turbo elite device was returned to the manufacturer and evaluated, it was discovered that there was a breach in the device's outer jacket.This report is being submitted due to the potential for exposure to manufacturing materials and accidental radiation.

• 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: 8602048
• Report Number: 1721279-2019-00075
• Device Sequence Number: 11310848
• Product Code: MCW
• UDI-Device Identifier: 00813132024703
• UDI-Public: (01)00813132024703(17)210227(10)FBE19B25A
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2019
• 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: 02/27/2021
• Device Model Number: 410-154
• Device Catalogue Number: 410-154
• Device Lot Number: FBE19B25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• 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: 04/18/2019
• Initial Report FDA Received Date: 05/10/2019
• 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
• Date Report Sent to FDA: 01/01/2005