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

Model Number 518-067

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

Patient Problems Cardiac Tamponade (2226); Iatrogenic Source (2498); Cardiac Perforation (2513)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

Patient weight was requested, but unavailable from the facility.Device was discarded by facility.Therefore, no evaluation is possible.There is no allegation that the device malfunctioned.

Event Description

A philips representative reported that on (b)(6) 2018 a cardiac lead management procedure commenced to extract three pacing leads, one right atrial (ra) and two right ventricular (rv).The procedure was being performed due to infection of leads.The first rv lead was extracted successfully using only a stylet.The second rv lead extraction was suspended because the spectranetics glidelight laser sheath device was stuck between the subclavian and brachiocephalic vein.They attempted to extract the ra lead instead, but the glidelight was stuck in the same position as it had been previously.They tried to extract the second lead again but it was adhered to another lead.They switched to using the spectranetics sightrail dilator sheath set and were able to complete the extraction of the second rv lead using the 16fr sightrail dilator.Again, they tried to extract the third lead but could not get enough traction with the lead locking device (lld) 518-067.They were using the glidelight after pulling on the lld and it was noticed that the patient's blood pressure was dropping.Cardiac tamponade was detected.Rescue efforts began immediately.A tear was discovered in the right atrial appendage (auricle) of the heart.The ra lead was capped and may be extracted at a later time depending on the patient's status.The lld was removed prior to ra lead being capped.The patient survived the procedure and was transferred to the critical care unit (ccu).

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8007483
• MDR Text Key: 125105433
• Report Number: 1721279-2018-00152
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/03/2018

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: 07/06/2020
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLP18G05A
• 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: 10/03/2018
• Initial Date FDA Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2018
• 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: 66 YR