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

Model Number	500-301
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2): patient''s date of birth unk a4): patient''s weight unk a5a./5b.): patient''s ethnicity/race unk b6): relevant tests/laboratory data unk b7): other relevant history unk d4): device serial number unk h3/h6): the device was not returned, thus no investigation could be completed and the reported complaint 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 lead extraction procedure commenced to remove a right ventricular (rv) and a left ventricular (lv) lead due to non function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics 12f glidelight laser sheath on the rv lead, the lead was successfully extracted.Next, while working to extract the lv lead, the blue cord (tail tube) separated at the bifurcate handle, and smoke emitted from the area of separation.Use of the glidelight was discontinued, and the blue cord was immediately cut midway between the coupler and handle.Then, the glidelight was removed from the body, and the lv lead was extracted at the same time with no reported patient harm.The patient survived the procedure.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
D4): device serial number populated.D9): the device was returned for evaluation on 30apr2024.G3): the device evaluation and investigation were completed 02may2024.H3): visual inspection of the glidelight device found a kink in the outer jacket of the tail tube, just proximal to the bifurcate handle.In the area of the kink, the outer jacket was melted and breached, with broken and exposed fibers observed.No additional damage was noted.H6): based on the device evaluation and investigation, this has been determined to be a use related failure.The failure observed was due to the force and angle applied to the tail tube.The device became kinked and broken fibers at the area of the kink produced heat, which created a breach in the outer jacket.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: GLIDELIGHT LASER SHEATH
• Common Device Name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 19176546
• Report Number: 3007284006-2024-00084
• Device Sequence Number: 6367801
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)251128(10)FGA23L20A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960042 S071
• 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): 05/08/2024

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: 11/28/2025
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: FGA23L20A
• 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: 04/24/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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 4298 LV LEAD.; MEDTRONIC 5076 RV PACING LEAD.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICES.
• Patient Age: 77 YR
• Patient Sex: Female