MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number UNAVAILABLE

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

Patient Problems Iatrogenic Source (2498); Atrial Perforation (2511)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Device model number, lot number, expiration date and udi unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove three leads: a right ventricular (rv) lead, a right atrial (ra) lead and a left ventricular (lv) lead due to a cied system/pocket infection.Spectranetics lead locking devices (lld ez) were inserted into each lead to provide traction for the leads to aid in extraction.The physician attempted to retract the helix on the ra and rv leads, but could only retract the helix on the rv lead.The ra lead was targeted for removal first.With use of a spectranetics 14f glidelight laser sheath, the physician was able to advance to the innominate area.However, in this area there was evidence of lead on lead binding, so he chose to focus efforts on removing the lv lead.He repeated this process twice with marginal results.After encountering stalled progression on both the ra and lv leads, the physician upsized to a 16f glidelight device and targeted the rv lead for removal.The physician was able to advance and break through the apparent lead on lead binding, which was hindering the removal of the ra and lv leads.He then focused his effort on removal of the lv lead using the same 16f glidelight device, which was successfully removed.The physician then targeted the rv lead again using the 16f glidelight device and a teflon outer sheath, and successfully extracted the rv lead with this technique.The remaining ra lead was then targeted again for removal using the 16f glidelight device, with no outer sheath.He was able to traverse down the superior vena cava (svc) but met some difficulty at the level of the svc/ra junction as there was a binding site, and the helix of the ra lead was still intact within the ra appendage.Finally the ra lead dislodged and was removed from the body.Anesthesia checked for an effusion, as they had done after the removal of each lead, and it was negative.However, approximately three minutes after this check, the patient's blood pressure started to drop slightly, and at this time there was an effusion present, being observed on transesophageal echocardiography (tee).Rescue efforts began immediately, including rescue balloon, pericardiocentesis and sternotomy.Injuries to the right atrial appendage and right atrium were discovered.The repairs were successful and the patient survived the procedure.There was no alleged malfunction of any spectranetics devices in use during the procedure.The physician felt both injuries were as a result of traction, which the lld was providing while inserted within the ra lead.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• 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: 11329841
• MDR Text Key: 240317125
• Report Number: 1721279-2021-00020
• Device Sequence Number: 1
• Product Code: DRB
• 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: 01/18/2021

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 Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 95