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

Model Number	420-159
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information available.Device evaluation: the device and marker band were evaluated on (b)(6) 2018.The reported complaint was confirmed.The marker band was a clean disconnect from the catheter.The band and epoxy on the catheter exhibits no damage.It was noted that one fiber may be dead at the tip of the device.The proximal coupler of the device showed no damage.Notification has been marked in this field to indicate this complaint is part of a voluntary field action.
Event or Problem Description
A procedure commenced to treat a left superficial femoral artery lesion.It was noted that the lesion was noted to be plaque.Once the laser catheter got through the lesion, the catheter was pulled back, and it was noted that the marker band had detached from the distal tip of the device, and was still present on the wire.The team used a balloon to retrieve the marker band.Another device was used to complete the case with excellent result.There was no reported patient harm.

• Brand Name: SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
• Common Device Name: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7825199
• Report Number: 1721279-2018-00114
• Device Sequence Number: 1143094
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: 00813132024765
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 08/08/2018
• 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: 08/15/2019
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH17H07A052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• 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: 08/08/2018
• Initial Report FDA Received Date: 08/28/2018
• 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: Hospitalization; Required Intervention
• Date Report Sent to FDA: 01/01/2005