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

Model Number 500-303

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pleural Effusion (2010); Great Vessel Perforation (2152); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

A4): patient''s weight unk.D4): device lot number, expiration date, serial number unk.Partial udi populated.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.H6): great vessel 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.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath on the ra lead, progress stalled and the decision was made to upsize to a 16f glidelight.Advancement was achieved on the ra lead, then efforts switched to the rv lead.Progress was made around the curve of the superior vena cava (svc) when pericardial and pleural effusions were detected via transesophageal echocardiography (tee).Rescue efforts began, including rescue balloon and sternotomy.A 1-2 cm perforation at the svc/ra junction was discovered and repaired.Both the ra and rv leads were removed post-sternotomy, and the patient survived the procedure.This report captures the 16f glidelight in the area 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
• Type of Device: 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 ; 719447-246
• MDR Report Key: 18370259
• MDR Text Key: 331048032
• Report Number: 3007284006-2023-00094
• Device Sequence Number: 1
• Product Code: MFA
• UDI-Device Identifier: 00813132020347
• UDI-Public: 00813132020347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500-303
• Device Catalogue Number: 500-303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 4574 RA PACING LEAD.; MEDTRONIC 6947M RV ICD LEAD.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American