MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS

Model Number	500-301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was returned and evaluated by a cross functional team on 10 feb 2022.The device was returned in two pieces; the device's working length was separated from the bifurcate handle.Fibers were broken and exposed at the proximal end of the working length and at the distal end of the bifurcate.The broken fibers appeared charred and the device's outer jacket appears melted.A kink was present in the device's working length, 15 inches from the distal tip.No breach to the outer jacket was detected in the kinked area.Historically, the manufacturer has seen this failure when excessive forces are applied to the device.The device becomes kinked, and broken fibers at the area of the kink produce laser energy, which creates a breach in the device's outer jacket.In this case, the device was separated completely into two pieces.This failure has been determined to be use related.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function.A spectranetics lead locking device (lld) was inserted into the lead to provide traction.The physician chose to use a spectranetics 12f glidelight laser sheath to attempt extraction.During the case, the physician was at an odd angle, pushing and bending the glidelight device when fibers broke through.Another glidelight device was opened and the procedure was completed with no reported patient harm.This event is being reported due to the device''s separation and unintended radiation exposure from the 12f glidelight device, potential for harm.

• Brand Name: SPECTRANETICS 12F GLIDELIGHT LASER SHEATH
• Common Device Name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
• 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: 13552844
• Report Number: 1721279-2022-00027
• Device Sequence Number: 17408251
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)231022(10)FGA21J16A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960042 S070
• 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
• Report Date (Section B): 12/15/2021

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: 10/22/2023
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: FGA21J16A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• 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: 12/15/2021
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2021
• 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: MEDTRONIC 5086 RV PACING LEAD; SECOND SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White