MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 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 11/07/2022

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unk.Patient's weight unk.Relevant tests/laboratory data unk.Other relevant history unk.Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.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.

Event Description

A lead extraction procedure commenced to remove a capped right ventricular (rv) and an active rv lead, along with a right atrial (ra) lead due to device infection and sepsis.Spectranetics lead locking devices (llds) and suture were used to provide traction.Multiple spectranetics devices (14f glidelight laser sheath, 11f tightrail sub-c rotating dilator sheath, 11f tightrail (long)) were used to successfully remove the ra lead, accomplished only after changing from lead to lead multiple times due to heavy scarring.Once the ra lead was successfully removed, the capped rv lead was targeted next due to the active rv lead having been stretched with insulation damage.Progress stalled in the superior vena cava (svc) with use of multiple devices, so the physician upsized to a 16f glidelight because the lead appeared to be snowplowing (bunching up on itself).Advancement was made through the svc, into the ra, and then into the rv.The physician monitored the patient''s blood pressure, vital signs, and transesophageal echocardiography (tee) with no evidence of injury.He proceeded further into the rv with the 16f glidelight and was still a few centimeters away from the tip of the lead when the rv lead tip pulled back abruptly with use of traction.Approximately 30 seconds after the lead and glidelight were removed, the patient''s blood pressure dropped.A pericardial effusion was detected via tee.Rescue efforts began immediately, including rescue balloon, pump and sternotomy.An rv apex perforation was discovered and repaired successfully.The active rv lead was removed post-sternotomy by creating a small opening in the patient''s ra and removing the rv lead using purse string sutures.The heart was sutured, the chest was closed, and the patient survived the procedure.This report captures the lld providing traction when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: SPECTRANETICS 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
• MDR Report Key: 15899959
• MDR Text Key: 304682229
• Report Number: 1721279-2022-00217
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2022
• 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: BOSTON SCIENTIFIC 4457 ACTIVE RV PACING LEAD; BOSTON SCIENTIFIC 4475 RA PACING LEAD; MEDTRONIC 4068 CAPPED RV PACING LEAD; SPECTRANETICS 11F TIGHTRAIL LONG DILATOR SHEATH; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White