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

Model Number	420-159
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	05/09/2022
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.Other relevant history unk.The device was discarded, thus no investigation could be completed.From photo provided, it has been confirmed that a breach in the device''s outer jacket and exposed fibers had occurred, causing unintended radiation exposure.The cause of the device damage could not be established.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the patient''s mid superficial femoral artery (sfa).A spectranetics turbo elite laser atherectomy catheter was chosen to treat the patient.During use in the patient, the device''s outer jacket had separated and no longer covered the fibers and inner lumen of the catheter.A new turbo elite of the same model was used to successfully complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.

• 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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14569216
• Report Number: 1721279-2022-00103
• Device Sequence Number: 5901185
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)240330(10)FBH22C23A
• 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
• Report Date (Section B): 06/01/2022

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: 03/30/2024
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH22C23A
• Was Device Available for Evaluation?: No
• 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: 05/09/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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: 6F INTRODUCER SHEATH MANUFACTURER UNK; COOK MEDICAL ROADRUNNER 0.014 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Unknown