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

Model Number	410-152
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3): the device was not returned, thus no investigation could be completed.H6): the device was not returned, thus the reported failure could not be confirmed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
A peripheral atherectomy procedure commenced, and a spectranetics turbo elite laser atherectomy catheter was used to treat the patient.During use, the device was loaded over the guide wire, and when retracted from the patient, damage was observed at the proximal end.Per photo provided, a breach in the outer jacket with broken and exposed fibers were visualized, just distal to the strain relief.Another turbo elite was used to complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
D4): additional information: device model number, lot number, catalog number, expiration date, serial number, udi now available and populated.D9): the device was returned for evaluation 24jul2023.G3): the device evaluation and investigation were completed 07aug2023.H3): visual inspection found a 2 inch breach to the outer jacket, beginning near the distal end of the strain relief, and the outer jacket was wrinkled, distal to the breach.In this area, the inner lumen was exposed, with heavy biologics observed.All fibers in the breached area were broken, and most were exposed and burnt at the proximal end, with none of the distal fibers burnt.The remainder of the catheter was in working condition.H6): based on device evaluation and investigation, the cause of the damage could not be established.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: 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 ; 719447-2465
• MDR Report Key: 17273876
• Report Number: 1721279-2023-00109
• Device Sequence Number: 5086172
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)241213(10)FBD22M01A
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 12/13/2024
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD22M01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 5F TERUMO INTRODUCER SHEATH; GUIDE CATHETER MANUFACTURER/SIZE UNK; GUIDE WIRE MANUFACTURER/SIZE UNK; SECOND SPECTRANETICS TURBO ELITE CATHETER; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Unknown