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 12/21/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

A lead extraction procedure commenced to remove right atrial (ra), right ventricular (rv) and left ventricular (lv) leads due to bacteremia.A 2 cm vegetation was noted to be present on the rv lead.Spectranetics lead locking devices (llds) were inserted into each of the leads to provide traction.The physician began by using a spectranetics 14f glidelight laser sheath, and successfully extracted the ra and lv leads.While working to extract the rv lead and before the glidelight device reached the area of the superior vena cava (svc)/ra junction, the patient's blood pressure dropped.A pericardial effusion was detected via transesophageal echocardiography (tee).Rescue efforts commenced immediately including use of a rescue balloon, cpr (cpr may have migrated the position of the balloon within the vasculature), and pericardiocentesis.Surgeon was contacted but was delayed.Sternotomy and bypass were performed; approximately 8-10 minutes passed between initial blood pressure drop and sternotomy.A 2 mm svc/ra junction perforation was discovered.Repair took 45 minutes and was successful; however, patient had gone too long with no blood volume and the patient died.The physician felt the perforation was due to traction forces, since the glidelight device did not reach the svc/ra junction when removing the rv lead.This report captures the lld providing traction to the rv lead when the svc/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
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13256157
• MDR Text Key: 283808339
• Report Number: 1721279-2022-00005
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023076
• UDI-Public: (01)00813132023076(17)231001(10)FLP21J30A
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21J30A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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 4076 RA PACING LEAD; MEDTRONIC 4298 LV LEAD; MEDTRONIC 6935 RV ICD LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White