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

Model Number 518-019

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

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

Event Date 11/04/2022

Event Type  Injury  

Manufacturer Narrative

The device was discarded, thus no investigation could be completed.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 right ventricular (rv) lead due to fracture/non-function.A spectranetics lead locking device (lld) was inserted into the lead to provide traction.A spectranetics 14f glidelight laser sheath was used, encountering stalled progress about halfway down the superior vena cava (svc).The glidelight's teflon outer sheath was then added, but progress stalled in the same location.The physician upsized to a 16f glidelight without an outer sheath in order to advance past the area, and was able to progress to where the tip of the glidelight reached the ra/rv junction.The patient's blood pressure dropped; the rv lead came free and was extracted.A pericardial effusion was detected.Rescue efforts began immediately, including rescue balloon, pericardiocentesis, bypass and sternotomy.A 2-3 cm posterior ra perforation was discovered and repaired.The patient survived the procedure.The physician believed that traction or lasing caused the perforation when the lead was pulled away from the binding site; however, significant tissue was present on the lead when it was extracted.This indicated that traction had caused or contributed to the perforation.This report captures the lld providing traction to the rv lead 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: 15838611
• MDR Text Key: 304087507
• Report Number: 1721279-2022-00211
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)231217(10)FLC21M15A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2023
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC21M15A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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 6935M RV ICD LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White