MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-062

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

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 05/16/2023

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove one right atrial (ra) and two right ventricular (rv) leads due to cied system/pocket infection.The ra and one rv lead were implanted 205 months; the other rv lead implanted 53 months.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Multiple spectranetics devices (tightrail mini rotating dilator sheath, tightrail (long), glidelight laser sheath) were used for the extraction procedure.The ra and rv leads (implanted 205 months) were successfully removed.However, during removal of the rv lead implanted 53 months, the lld was providing traction, and an effusion was detected via transesophageal echocardiography (tee), growing near the rv apex.Rescue efforts included performing a pericardiocentesis and placing a drain, and the patient stabilized.No further intervention was required, and the patient survived the procedure.This report captures the lld present in the rv lead when a suspected rv apex perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

A2): patient's date of birth unk.A4): patient's weight unk.B7): other relevant history unk.D4): device lot number, expiration date 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): cardiac perforation is a known risk of complication with use of the lld.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: LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 17051732
• MDR Text Key: 316475772
• Report Number: 1721279-2023-00100
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• 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: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL (LONG) DILATOR SHEATH; SPECTRANETICS TIGHTRAIL MINI DILATOR SHEATH; ST. JUDE MEDICAL 1688TC RA PACING LEAD; ST. JUDE MEDICAL 1688TC RV PACING LEAD; ST. JUDE MEDICAL 2088TC RV PACING LEAD
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White