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

Model Number 518-062

Device Problem Break (1069)

Patient Problems Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

Patient age unavailable, date of birth unavailable.Patient weight unavailable.Device lot number and expiration date unavailable.Device manufacture date unavailable because lot number is unavailable.

Event Description

A lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead due to non function.Spectranetics lead locking devices (lld's) were place in both leads to provide traction on the leads during removal attempts.A spectranetics glidelight laser sheath was used first to attempt removal of the rv lead but the physician experienced stalled progression in the innominate vein.He then utilized a spectranetics medium 43cm visi sheath along with the 14f glidelight, but could not get down to the superior vena cava (svc) on either lead.The physician then chose to use a 16f glidelight device with a large 33cm visi sheath and could advance a little further down the leads.He then chose to use a spectranetics 13f tightrail device on both the ra and rv leads, and although the physician still had traction, the leads looked like they were unraveling.He met stalled progression where the innominate vein transitioned into the svc.There appeared to be a large calcification on both leads right near the svc, so the physician switched to a spectranetics 13f tightrail sub-c device.He was able to make some progress as he attempted to remove the ra lead, but during this time, the ra lead and the lld in the ra lead broke.The physician then switched attempt to remove the rv lead.As he was advancing the device past the lead on lead binding high in the right atrium, he pulled the device back off the rv lead, which was still fixed in the right ventricle.At this point, the patient's blood pressure dropped.Rescue efforts began immediately.A sternotomy was performed, an svc tear was discovered, and was successfully repaired (please reference mdr 1721279-2020-00004 which captures the svc tear which occurred during the procedure).Both the ra and rv leads were removed post sternotomy, after the repair was complete.The patient survived the procedure.This report is being submitted for the lld which broke when the ra lead broke, due to the potential for serious injury if an lld break were to recur.There was no reported patient harm when the lld broke in this event.

• 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: 9559485
• MDR Text Key: 199991451
• Report Number: 1721279-2020-00005
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNAVAILABLE
• 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
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention