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

Model Number 518-062

Device Problem Fracture (1260)

Patient Problem Unspecified Infection (1930)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This procedure was to extract one cardiac lead due to cied/system/pocket infection.The lead was prepped with a spectranetics lead locking device.The lead locking device fractured.The procedure was completed via a transatrial approach.The patient survived the procedure.

Manufacturer Narrative

Device evaluation: this device was physically evaluated and found to be intact.The core mandrel is twisted; however this was caused during use of the device.The device appears to have deployed correctly and does not have any evidence of malfunction.This device failure (use related, as found) is unlikely to cause or contribute to patient harm.

Manufacturer Narrative

Device evaluation: physical evaluation of this device noted that the device was fully intact and appeared to have been heavily used.There was no evidence of device failure to perform as intended.Additional evaluation with the facility indicated that the cardiac lead is the device that failed/broke preventing removal of the lld.

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: jason hearn ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-236
• MDR Report Key: 6223221
• MDR Text Key: 63910646
• Report Number: 1721279-2017-00004
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/08/2018
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP16F08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• 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: CARDIAC LEAD,MDT 6944 (IMPL.96MOS)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention