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

Model Number	500-303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Great Vessel Perforation (2152)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non-function and fracture.A right atrial (ra) lead was present in the patient, but was not targeted for extraction.A spectranetics lld ez lead locking device (lld ez) was inserted into the lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath, minimal progress was made, and a spectranetics visisheath dilator sheath was added to obtain more progress into the subclavian.Advancement stalled about midway, so switched to a spectranetics 13f tightrail rotating dilator sheath.Moving towards the innominate/superior vena cava (svc) junction, it stalled again, and decided to switch back to the glidelight and visisheath, but could only advance just before the svc.The patient¿s blood pressure dropped slightly, and upon removal of the glidelight, the pressure dropped rapidly.Rescue efforts began, including cpr and sternotomy.Perforations in the innominate vein and the svc were discovered and repaired (mdr # 3007284006-2025-00234).The decision was made to abandon the extraction deeming it too risky to continue; therefore, the rv lead, along with the lld ez, were cut and capped and remained in the patient (mdr # 3007284006-2025-00235).There was no attempt to unlock the lld ez.The patient survived the procedure.This report captures the 16f glidelight in use when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.A3b) patient gender - not available from facility.A4) patient weight - not available from facility.A5) patient ethnicity - not available from facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.D4) device serial number - not available from facility.H3) the glidelight was discarded, thus no product investigation was performed.H6) per ifu, perforation is listed as a potential adverse event with use of the glidelight device.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: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 23560740
• Report Number: 3007284006-2025-00234
• Device Sequence Number: 21365404
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)270721(10)0303530141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: 0303530141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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 5076 RA PACING LEAD; MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ LEAD LOCKING DEVICE; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Race: White