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

Model Number 518-062

Device Problem Failure to Advance (2524)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Perforation (2001)

Event Date 03/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient was to undergo a lead extraction procedure to remove one ra lead and one rv lead due to infection.Each of the leads was prepped with an lld-ez((b)(4)).The procedure was started with extraction of rv lead using 12fr slsii but the device was not advanced at the lead on lead bind site.The physician switched to the ra lead but again the device was not advanced at the adhesion.The device was up-sized to 14fr slsii.The ra lead was extracted with counter traction and then the rv lead was extracted successfully.About 5 minutes after the rv lead was extracted, the patients blood pressure dropped from 105 to 40 mmhg.The cardiac surgeon immediately performed a small incision and confirmed a perforation at the cadiac apex.Bleeding was stopped after performing drainage and hematoma evacuation.The patient survived the procedure.This report is being made on the lld as it was likely the mechanism of injury as it was the traction platform used when the injury occurred at the implant site of the lead.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 5564980
• MDR Text Key: 42410489
• Report Number: 1721279-2016-00049
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/02/2017
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP15J02A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2015
• 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: 93 YR