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

Model Number	417-152
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable, although requested.The component code and health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter (b)(4).
Event or Problem Description
It was reported to a philips sales representative (not present at the procedure) from the facility/physician on (b)(6) 2021 that a peripheral atherectomy procedure commenced on (b)(6) 2021 to treat a slightly calcified soft tissue lesion using a retrograde access approach.The indication for this procedure or the lesion location was unavailable to the manufacturer.According to the report, the physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient, and after calibrating the device and prior to putting it into the patient's body, light was noticed shining out from the tubing of the device.They removed the device from the laser system and opened a second laser catheter.The procedure was then completed without event and the patient survived with no reported injury.The device was discarded at the facility and therefore is not available for evaluation.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
Additional Manufacturer Narrative
H6): in the initial mdr, the component code listed in the narrative in h11.Was inadvertently typed as "722".Component code 772 has now been entered to accurately reflect the component described in the event.Added code: 2199.

• 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: 11602157
• Report Number: 1721279-2021-00050
• Device Sequence Number: 17058759
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)220420(10)FAZ20C19B
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 04/20/2022
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ20C19B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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 SYSTEM; SPECTRANETICS TURBO ELITE LASER CATHETER
• Outcome Attributed to Adverse Event: Other