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

Model Number	414-151
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information available.Operator of device code unavailable at this time.
Event or Problem Description
A vascular intervention procedure commenced to treat an anterial tibial lesion.When the laser catheter was plugged into the laser system, visible laser light (aiming light) was observed coming out from an area just distal to the white, wire insertion coupler.The laser was never calibrated, nor was it inserted into the patient.Per report, it appeared that the device jacket did not fully encase the laser bundle.Another device was used to successfully complete the procedure.There was no reported patient harm.Although the device was not calibrated in this case, this event is being reported due to the potential with recurrence for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation if the device had been calibrated.
Additional Manufacturer Narrative
Code accepted by fda now populated within this field.Device available for evaluation on 25 july 2018.Device returned to manufacturer on 25 july 2018.Method and results codes added after device evaluation.Device evaluation: in the initial mdr, it was reported that the device jacket did not fully encase the laser bundle.The actual device was evaluated on 26 july 2018.The device was plugged in to simulated laser light.There were approximately 20 dead fibers at the tip of the device.The area described in the original complaint glowed red with the simulated light.Multiple broken fibers were present in this area, causing the area to glow red.However, it was discovered during evaluation of the device that there was no breach in the jacket and the fiber bundle was fully encased.Therefore, there was no potential exposure to manufacturing materials/accidental radiation occurrence, nor would there be with recurrence of this specific failure mode.With the new above information, this is no longer a reportable event.

• 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: 7671736
• Report Number: 1721279-2018-00082
• Device Sequence Number: 13683139
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: 00813132024710
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018
• 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: 03/14/2020
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY18C06A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/01/2018
• 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: SPECTRANETICS CVX-300 EXCIMER LASER.
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005