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

Model Number 518-062

Device Problems Material Separation (1562); Material Integrity Problem (2978)

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

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

Patient date of birth unavailable; patient weight unavailable.

Event Description

A procedure commenced to remove two leads, both right ventricular (rv) due to non functional leads and upgrade to a new system.The physician successfully extracted one of the rv leads using a glidelight device, a lead locking device (lld) and a 33cm visi sheath.During attempted extraction of the second rv lead, he encountered stalled progression approximately 60% down the lead.In attempt to progress the laser, the lld broke due to pulling forces, with no consequence to the patient.The lld continued to be used, however, because there was enough length on the lld to provide traction with additional use of kelly clamps.The visi sheath then was able to progress past the area where the devices first stalled, but there was not enough length on the visi sheath to complete the extraction.The physician ultimately chose to select a longer visi sheath (43cm) without use of a laser catheter.The device was able to reach the distal tip of the lead.The lead then came out of the rv.The visi sheath and lead (with lld) were pulled out together.Within 10 minutes, however, the patient's blood pressure dropped.Rescue efforts began immediately, including pericardiocentesis and sternotomy.An injury was discovered at the rv apex.The repair to the injury was made, and the patient survived the procedure.

• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 7825278
• MDR Text Key: 118527837
• Report Number: 1721279-2018-00117
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/09/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2020
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP18C05A
• 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: 08/09/2018
• Initial Date FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2018
• 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: 58 YR