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

Model Number	417-156
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was returned and evaluated on 15 october 2020 by a cross functional team.The introducer sheath and guide wire were returned with the device.The device was returned with no portions of the device missing.An obvious breach to the outer jacket was seen 3cm from distal tip and extending 5.5cm toward the device's proximal coupler.There were 3-4 broken fibers identified in the area of the breach.Due to the size of the breach and the damage present to the outer jacket, this event is a confirmed use related failure.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a heavily calcified lesion in the patient's superficial femoral artery (sfa).The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.During use of the device, it was reported the device separated at the tip while being used within the patient.The portion of the catheter was reportedly retrieved from the patient with no reported patient harm.On 15 oct 2020 the device was evaluated and it was confirmed there were no portions of the device missing.This report is being submitted 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: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10692250
• Report Number: 1721279-2020-00213
• Device Sequence Number: 304602
• Product Code: MCW
• UDI-Device Identifier: 00813132024741
• UDI-Public: (01)00813132024741(17)220601(10)FBG20E18C
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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): 09/17/2020

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: 06/01/2022
• Device Model Number: 417-156
• Device Catalogue Number: 417-156
• Device Lot Number: FBG20E18C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2020
• 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: Required Intervention