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 Great Vessel Perforation (2152); Pericardial Effusion (3271)

Event Date 10/12/2023

Event Type  Death  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Multiple spectranetics devices (11f tightrail rotating dilator sheath, 14f glidelight laser sheath, 16f glidelight laser sheath) were used during the procedure.The ra lead was extracted successfully.However, using the 16f glidelight during extraction of the rv lead, a pericardial effusion was detected via transesophageal echocardiography (tee).Rescue efforts began, including cpr, pericardiocentesis, rescue balloon, and sternotomy.A superior vena cava (svc) perforation was detected, but the rescue efforts were unsuccessful and the patient did not survive.This report captures the 16f glidelight in use when the perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics or philips device in use during the procedure.

Manufacturer Narrative

D4): device lot number, expiration date, serial number unk.Partial udi populated.H4): device manufacture date unk because lot number unk.H6): great vessel perforation and death 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
• 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: 18067124
• MDR Text Key: 327309734
• Report Number: 3007284006-2023-00058
• 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: 11/03/2023

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
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2023
• 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: PHILIPS LASER SYSTEM; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1688TC RA PACING LEAD; ST. JUDE MEDICAL 1688TC RV PACING LEAD
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White