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 Great Vessel Perforation (2152); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unk.Patient's weight unk.Device lot number and expiration date unk.The device was discarded, thus no investigation could be performed.Device manufacture date unk because lot number unk.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to needing an mri.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Using a spectranetics 14f glidelight laser sheath and a spectranetics large visisheath dilator sheath to attempt extraction of the ra lead, the physician noted that the tip of the ra lead was adhered to the rv lead, and the visisheath was used to break apart the binding on the two leads.The ra lead then came free, and a pericardial effusion was noted on transesophageal echocardiography (tee) with a slight blood pressure drop, blood pressure controlled by anesthesia.Rescue efforts began, and the decision was made to drain the effusion via pericardiocentesis.A suspected superior vena cava (svc)/ra junction or ra perforation was suspected (injury location was not confirmed because a sternotomy was not performed).Once the pericardium was drained, the patient remained stable and the injury was assumed to have clotted off.Further information from the rep indicated that the physician felt the injury was as a result of traction, since the glidelight device never reached the suspected injury site, and there were no hemodynamic changes noted during and after use of the visisheath device.Both the ra and rv leads were extracted per report.This report captures the lld present within the ra lead when the suspected svc/ra or ra perforation occurred.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
• MDR Report Key: 12733671
• MDR Text Key: 281748207
• Report Number: 1721279-2021-00208
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH; ST. JUDE MEDICAL 1346T RV ICD LEAD; ST. JUDE MEDICAL 1488TC RA PACING LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 58 YR