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	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2): patient''s date of birth unk.D4): device serial number unk.H3/h6): the device was not returned, thus no investigation could be completed and the cause of 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 lead extraction procedure commenced to remove a right ventricular (rv) lead due to occlusion.A right atrial (ra) lead was present in the patient as well, but was not targeted for extraction.A spectranetics lld ez lead locking device (lld ez) was inserted into the rv lead to provide traction.Beginning with a spectranetics 12f glidelight laser sheath, heavy calcification and occlusion was present in the innominate vein.With traction, the rv lead fractured and was pulled back into the innominate region, leaving a 3-4 cm remnant (rv distal tip and outer insulation) in the area.The lead conductors and lld were removed from the patient, with no further attempts made to retrieve the lead remnant.Upon examination of the glidelight, the outer sheath was fractured, with the damage believed to be as a result of the heavy calcification encountered in the vasculature.After the procedure, no access could be attained to re-implant new leads, so plans were made to follow up with a right sided implantation at a later date.The procedure was completed with no reported patient harm.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 to the manufacturer 12jun2024.G3): the device evaluation and investigation were completed 13jun2024.H3): visual inspection found kinks in two areas of the working length, approximately 13 cm and 15 cm from the distal tip.At 13 cm, multiple broken fibers and a breached and melted outer jacket were observed.At 15 cm, functional testing revealed multiple dead fibers, but no breach was present.H6): based on the device evaluation and review of complaint information, this failure has been determined to be patient condition related.Historically, the manufacturer has seen this failure when forces from heavy calcification are applied to the working length of the device.The device becomes kinked on the calcification, resulting in broken fibers.The broken fibers in the area of the kink produce heat, which results in melting of the outer jacket, creating a breach.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: 19325862
• Report Number: 3007284006-2024-00102
• Device Sequence Number: 11434428
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)6004(10)FGA23M20A
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 01/04/2026
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: FGA23M20A
• 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: 06/13/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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: BOSTON SCIENTIFIC 7742 RV PACING LEAD; BOSTON SCIENTIFIC RA PACING LEAD MODEL UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ LEAD LOCKING DEVICE
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White