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

Model Number	423-135-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information unavailable.Device has been requested for return but is not available to manufacturer at this time.
Event or Problem Description
During a vascular intervention to treat peripheral artery disease in the patient's superficial femoral artery, a spectranetics turbo elite device was in use.During the procedure, the device's radiopeque marker band disconnected while device was being used in the patient.Ring came apart inside the patient.The physician was able to remove the marker band using a filter wire, with no reported patient harm.
Additional Manufacturer Narrative
The manufacturer was informed by the sales rep on 16 may 2019 that the turbo elite device had been discarded so it will not be returned for evaluation.Method, results and conclusions codes have been populated to reflect that the turbo elite device will not be available for return; the device has been discarded.The cause of this reported event could not be established.

• 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: 8612807
• Report Number: 1721279-2019-00078
• Device Sequence Number: 19361677
• Product Code: MCW
• UDI-Device Identifier: 00813132024796
• UDI-Public: (01)00813132024796(17)200905(10)FBL18H25A
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2020
• Device Model Number: 423-135-01
• Device Catalogue Number: 423-135-01
• Device Lot Number: FBL18H25A
• 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: 04/24/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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: 0.035 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; 0.035 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005