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); Pericardial Effusion (3271)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.A3b) gender - not available from facility.A4) patient weight - not available from facility.B7) patient information regarding 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 glidelight devices.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 atrial (ra) and a right ventricular (rv) lead due to bacteremia.The rv lead was an advisory riata lead that showed obvious cable externalization under pre-case x-ray and fluoro.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Utilizing spectranetics 13f tightrail sub-c rotating dilator sheath, the ra lead was successfully removed.Targeting the rv lead with the same tightrail, it progressed through the subclavian; however, stopped at the innominate/superior vena ceva (svc) junction.Switching to a spectranetics 16f glidelight laser sheath, progress was made through the svc and in to the heart, but stalled at the point where the cable externalization occurred between the two shocking coils.Attempting to pull the glidelight off to possibly utilize a spectranetics visisheath dilator sheath, it was noted that the rv lead was free from the ventricle.A transesophageal echocardiogram (tee) confirmed the lead was free from the apex.High voltage cables were pulled directly from the pocket into the lead body, while the glidelight was off the lead and outside the body.Because the lead was apparently free from the ventricle per tee, gentle traction was applied again pulling on just the lead before the glidelight was reloaded.The lead was still not moving; therefore, it was decided to use the glidelight with a visisheath.However, the patient¿s blood pressure started dropping, thus, tee was performed and a pericardial effusion was noted.The blood pressure started dropping more rapidly and tamponade was observed.Rescue efforts began, including rescue balloon, chest compressions, pericardiocentesis, and sternotomy.A innominate/svc junction perforation was discovered and repaired, and the patient survived the procedure.This report captures the 16f glidelight device in use when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: ayse kharodawala ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 24811248
• Report Number: 3007284006-2026-00126
• Device Sequence Number: 12268726
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: (01)00813132020347(17)270130(10)0303391765
• 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): 04/07/2026

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: 0303391765
• 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: 03/18/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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: ABBOTT 1488TC RA PACING LEAD; ABBOTT 1580 RV ICD LEAD; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White