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

Model Number 518-019

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

Patient Problems Iatrogenic Source (2498); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight is unavailable from the facility.Device lot number and expiration date are not available from the facility.The device was discarded by the user.Device manufacture date is dependent on the device lot number, thus is unavailable.The device was discarded.There is no allegation of a malfunction.Therefore, no device evaluation will be performed.

Event Description

A cardiac lead management procedure commenced to extract two redundant/nonfunctional implantable cardioverter defibrillator (icd) right ventricular (rv) leads.The first lead attempted to extract was the active lead 6947.After a stylet was inserted and torque applied, the lead came apart leaving no inner lumen.Suture was tied to conductor cable and outer insulation as traction platform and a spectranetics 13fr tightrail rotating dilator sheath was inserted over the lead.Slim to no progress was made in freeing the lead, when the lead broke.After this a spectranetics #2 lead locking device (lld) was inserted on the capped 6936 lead and the 13fr tightrail was used to free the lead.Tightrail was effective in freeing the lead to 1cm to the distal end of the right ventricular (rv) lead.When reaching the most distal portion of the rv apex it was noted that counter traction was pulling part of the apex into the sheath.Counter traction was used to dislodge the lead.Shortly after lead came free the patient's blood pressure dropped and effusion was noted on transesophageal echocardiogram (tee).Rescue efforts commenced and sternotomy was performed.Cardiothoracic surgeon diagnosed the cause of bleeding as an rv apex perforation.The perforation was fixed without the patient going on bypass.One rv lead (6936) was removed during sternotomy, the other rv lead was left in place.

• 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: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8895566
• MDR Text Key: 154407281
• Report Number: 1721279-2019-00142
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 01/01/2005,07/19/2019

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: 518-019
• Device Catalogue Number: 518-019
• 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: 07/19/2019
• Initial Date FDA Received: 08/14/2019
• 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
• Treatment: MEDTRONIC 6936 LEAD; MEDTRONIC 6947 LEAD; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR