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

Model Number	420-159
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's date of birth, age unk.Patient's gender unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was not returned, thus no investigation could be completed.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the patient's proximal common femoral artery.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.The procedure was completed with no reported patient harm.However, upon removal of the turbo elite device from the patient's body, there was a shear/tear observed in the catheter.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
D9): the device was returned to the manufacturer on 15 feb 2022.G3): the device evaluation and investigation were completed on 17 feb 2022.H3): device evaluation: the device was returned and evaluated by a cross functional team.An obvious breach to the device''s outer jacket was visible.There were twists and a kink observed in the outer jacket, but no breaches to the jacket were noted in these areas.The outer jacket was ripped, starting at the device''s port fuse and extending to approximately two inches from the distal tip of the device.No broken fibers were seen in the area of the breach; however, the mandrel, fibers and inner lumen were exposed.Likely during removal of the device from the patient, the guide wire was pulled laterally away from the device which caused the outer jacket to rip.This has been determined to be a use related failure.

• 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
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13344850
• Report Number: 1721279-2022-00013
• Device Sequence Number: 1752459
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)231102(10)FBH21K27A
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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: 11/02/2023
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH21K27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.014 GUIDE WIRE MANUFACTURER UNK.; 6F INTRODUCER SHEATH MANUFACTURER UNK.; GUIDE CATHETER MANUFACTURER AND SIZE UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Sex: Unknown