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

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

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

Event Date 01/26/2024

Event Type  Death  

Manufacturer Narrative

A2): patient''s date of birth, age unk.A3): patient''s gender unk.A4): patient''s weight unk.A5a./5b.): patient''s ethnicity/race unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.D4): device model number, lot number, catalog number, expiration date, serial number, and udi unk.H3): the device was discarded, thus no investigation could be completed.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.

Event Description

A lead extraction procedure commenced.Lead location, extraction indication, and traction platform unk.A spectranetics glidelight laser sheath was used to treat the patient.During use, a superior vena cava (svc) perforation was discovered.A right ventricular (rv) avulsion was discovered as well, but information provided did not implicate any device as the cause for the avulsion.Intervention to repair the svc perforation unk; however, the event resulted in the patient''s death.This report captures the glidelight in use when the svc perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of the glidelight device during the procedure.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to lead fracture.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.A spectranetics glidelight laser sheath was used to treat the patient.The ra was able to be removed without issues.The rv lead was removed as well; however, after removal of the lead, a large pericardial effusion was detected via transesophageal echocardiography (tee).Rescue efforts began, including pericardiocentesis and thoracotomy.A large superior vena cava (svc) perforation was discovered.Repair was attempted, but unfortunately the patient did not survive.This report captures the glidelight in use when the svc perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

A2): patient's age populated.A3): patient's gender populated.A5b.): patient's race populated.B5): edited to populate additional/corrected information.Additional information: case detail, devices in use.Corrected information: no rv avulsion occurred, as reported in the initial mdr.B6): relevant tests/laboratory data populated.B7): other relevant history populated.D10): traction platforms, lead information populated.G3): additional/corrected information received 23feb2024.H6): addition of hecc code 3271.Addition of heic codes 4641 and 4624.All other codes remain applicable as submitted within the initial mdr.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: 18761684
• MDR Text Key: 336023507
• Report Number: 3007284006-2024-00040
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: LEAD(S) MANUFACTURER/MODEL/TYPE UNK.; RA LEAD MANUFACTURER/MODEL/TYPE UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICES.; ST. JUDE MEDICAL DURATA RV ICD LEAD.; TRACTION PLATFORM MANUFACTURER/MODEL/TYPE UNK.
• Patient Outcome(s): Required Intervention; Life Threatening; Death
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Race: White