MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

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

Patient Problems Perforation of Vessels (2135); Iatrogenic Source (2498)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

Date of birth unknown.Weight unknown.

Event Description

A lead extraction procedure commenced for the extraction of a right ventricle (rv) and a right atrium (ra) lead due to infection.The rv and ra were implanted in 2006.Spectranetics lead locking devices and 14f glidelight were being used in the procedure.Progress had stalled on both of the lead attempts in the area of the subclavian vein due to adhesion.They then used a mechanical device manufactured by cook, and the lead began to stretch out.They removed the ra lead using a snare (manufacturer unknown) from the femoral access site.They then attempted to remove the rv lead also using the snare and lasing at the proximal end of the lead.It was then that they noticed bleeding had increased from the pocket and a cautery knife was used to obtain hemostasis in the area of the pocket, but it was not successful.They then discovered that there was a tear in subclavian vein and rescue interventions commenced.They repaired the injury to the subclavian by suturing.After the repair, the procedure continued and they removed the rv lead successfully using the snare.Patient survived the procedure.The physician mentioned that felt this event occurred due to either too much traction or too much peeling using the cautery knife.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9687454
• MDR Text Key: 180209570
• Report Number: 1721279-2020-00028
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)210501(10)FLP19E01A
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,01/15/2020

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: 05/01/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP19E01A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR