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 03/22/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) dual coil lead (implanted in 2004) due to lead failure.A spectranetics lead locking device (lld) was inserted into the lead to provide traction.The physician used a spectranetics 16f glidelight laser sheath, advancing with power over the lead through the subclavian vein, into the innominate vein and onto the proximal portion of the lead's superior vena cava (svc) coil.With appropriate countertraction from the lld, the glidelight was able to advance over the lead without power through the svc, right atrium, and onto the proximal section of the lead's distal coil.A short burst of laser was applied until the glidelight was halfway over the coil, and two very short bursts were applied around the lead's tip, but no laser was applied as the lead tip was brought into the glidelight sheath to increase counter traction.The rv lead tip came free after approximately 30-45 seconds of counter traction.The lead was removed with no issues reported.However, approximately 1-2 minutes after the lead was extracted, a small and growing pericardial effusion was noted via transesophageal echocardiography (tee) and the patent's blood pressure dropped; the team suspected an rv perforation.Rescue efforts began, including a subxiphoid incision and anesthesia support to sustain normal blood pressure.The perforation could not be primarily repaired through the subxiphoid incision, so a sternotomy followed.A 1-2 cm perforation was confirmed at the anterior rv apex, and was successfully repaired with a patch and sutures.A new rv lead and generator were implanted and the patient was awake, alert and oriented approximately one hour post procedure.The operator believed that after reviewing fluoroscopic images of the procedure, the perforation occurred when the tip of the rv lead came away from the rv apex.This report captures the lld providing traction to the rv lead when an rv apex perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

Patient's weight unk.The device was discarded, thus no investigation could be completed.

• 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: 14147749
• MDR Text Key: 290456223
• Report Number: 1721279-2022-00068
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)240118(10)FLP22A14A
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2024
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP22A14A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• 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 6944 RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White