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

Model Number	500-301
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	06/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) lead due to infection.A spectranetics lld ez lead locking device (lld ez) was inserted into the lead to provide traction.Beginning with a spectranetics 12f glidelight laser sheath, advancement was made through the innominate region and into the superior vena cava (svc) when the patient's blood pressure dropped.A pericardial effusion was detected via transesophageal echocardiography (tee), and rescue efforts began, including rescue balloon and thoracotomy.An anterior, 6 cm perforation extending from the innominate, through the svc, and into the ra was discovered and repaired.Post-thoracotomy, the ra lead was removed, and the patient survived the procedure.This event captures the 12f 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
H3): the device was discarded, thus no device evaluation could be completed.H6): perforation of vessels, great vessel perforation, and cardiac perforation are known risks of complication 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 19680381
• Report Number: 3007284006-2024-00141
• Device Sequence Number: 11535738
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)250926(10)FGA23J21A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2024

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 Expiration Date: 09/26/2025
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: FGA23J21A
• 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: 06/14/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• 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: SORIN MEDICAL 52ERJB TINED RA PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian