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

Model Number	410-152
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a plaque lesion in the mid anterior tibial (at) vessel.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.When they were going to insert the turbo elite device for a second run through the lesion, they noticed the tip of the catheter was melted.Another turbo elite device was used to complete the procedure with no reported patient harm.Photos of the returned device reveal a breach in the device's outer jacket with exposed, broken fibers.Based on the photos received by the manufacturer, this event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
Patient's weight unk.Relevant tests/laboratory data unk.Other relevant history unk.Photos have been taken of the returned device, but evaluation and investigation pending.Supplemental mdr will be submitted after evaluation and investigation are completed.
Additional Manufacturer Narrative
G3): device evaluation and investigation were completed on 05 nov 2021.H6): device evaluation: the device was returned and evaluated by a cross functional team.A breach to the outer jacket and broken fibers were seen approximately 1.5 in from the device''s distal tip.The device''s outer jacket was twisted 0.5 in from the device''s distal tip, but no breach or broken fibers were seen in this area.The twist and breach to the outer jacket likely occurred during removal of the device before attempting a second pass through the lesion.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: 12694434
• Report Number: 1721279-2021-00196
• Device Sequence Number: 19957890
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)230709(10)FBD21F29A
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 09/27/2021

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: 07/09/2023
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD21F29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• 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: 09/27/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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: 2ND TURBO ELITE DEVICE TO COMPLETE CASE; ABBOTT 0.014 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic