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 04/29/2021

Event Type  Injury  

Manufacturer Narrative

The component code and health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter (b)(4).

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to non function.Spectranetics lead locking devices were inserted into each of the leads to provide traction to aid in extraction.It was reported that the patient had a small effusion prior to the procedure beginning.After the ra lead had been successfully removed, the patient's blood pressure dropped slightly.The case was continued, and the rv lead was also successfully removed and then re-implantation of new leads followed the successful extractions.However, at that time, the effusion showed an increase from the baseline.It was reported that a right atrial perforation had occurred.The physician then decided they needed to perform a pericardiocentesis, and 255cc of blood was removed.The physician felt the blood pressure drop was as a result of invagination.This report is being submitted due to the lld providing traction in the ra lead and traction may have caused or contributed to the event.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be performed.H6): added codes: 4755, 4621, and 4619.

• 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: 11894036
• MDR Text Key: 260137254
• Report Number: 1721279-2021-00097
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)220813(10)FLP20H11A
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20H11A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 06/06/2021
• Supplement Dates FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; ST. JUDE MEDICAL 1488TC RA PACING LEAD; ST. JUDE MEDICAL 1488TC RV PACING LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 98