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

Model Number	410-154
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable from facility, although requested.Device evaluation: the device was returned and evaluated by a cross functional team on (b)(6) 2020, and it was at that time that this event was determined to be reportable.The team identified damage located distally of the guide wire port.The device appeared to be pinched.The distal marker band also appeared to be flattened by a compressive force and a crack was identified in the device's distal marker band.Under magnification, the team identified and confirmed two breaches (one 1.5cm from the device's distal tip and one just distal of the device's marker band.) next, the team used a 0.014mm guide wire to examine for patency.Although resistance was noted, the guide wire passed through the lumen, confirming patency.The reported issue of the device not loading onto the guide wire was not confirmed.It could not be determined when the damage to the device occurred.
Event or Problem Description
A peripheral vascular intervention commenced and during preparation for use, a spectranetics turbo elite laser atherectomy catheter was found to not load on the guide wire.It was reported that the device never entered the body.The physician used another device and the case was completed successfully with no reported patient harm.The device was returned to the manufacturer and was evaluated on (b)(6) 2020.From the device evaluation findings, it was determined that this is a reportable event due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/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: 9811213
• Report Number: 1721279-2020-00048
• Device Sequence Number: 610515
• Product Code: MCW
• UDI-Device Identifier: 00813132024703
• UDI-Public: (01)00813132024703(17)211219(10)FBE19M17A
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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): 01/31/2020
• 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: 12/19/2021
• Device Model Number: 410-154
• Device Catalogue Number: 410-154
• Device Lot Number: FBE19M17A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• 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: 02/20/2020
• Initial Report FDA Received Date: 03/10/2020
• 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