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

Model Number 518-062

Device Problem Failure to Advance (2524)

Patient Problems Calcium Deposits/Calcification (1758); Unspecified Infection (1930); Pericardial Effusion (3271)

Event Date 01/16/2014

Event Type  Injury  

Event Description

Cardiac lead extraction case to remove two leads due to a cied system infection.Both leads were prepped with an lld ez and the physician began extraction using a cook dilating sheath.The cook dilating sheaths made successful advancement to the area of the innominate svc junction; both leads contained heavily calcified lesions so the physician decided to use a 14fr glidelight with a visisheath (m).The physician began extracting the 4068 rv cardiac lead (implanted 180 months) but was still unable to advance.A 16fr glidelight was then used on the 4068 lead and was successfully extracted without complication.The 14fr glidelight was then utilized to attempt extraction of the 4004 rv cardiac lead (implanted 276 months); progress was made to approximately 1cm proximal to the lead tip.Hemodynamic changes were then noticed upon applying traction on the lld ez, these changes resolved when the physician released traction.Counter traction was applied on the lead using the lld ez several times without showing any signs of lead tip release, at this time a small effusion was discovered on echo.Another attempt to hold traction finally released the lead and repeat echo determined that the effusion had grown and the blood pressure began to drop.A sternotomy was performed and the ct surgeon repaired a small perforation at the rv apex.Intervention was successful and the patient survived.This injury type is most likely caused in this case due to the condition of cardiac wall tissue at the implantation site and the use of traction.In this case an lld ez was used as the traction platform.

Manufacturer Narrative

The lld ez was not returned for evaluation however the concomitant devices that were returned were evaluated; this includes a 14fr glidelight, a 16fr glidelight, and a visisheath.There were no issues found with these devices that could have caused or contributed to this adverse event.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: sondra chandler rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472530
• MDR Report Key: 3590863
• MDR Text Key: 4167342
• Report Number: 1721279-2014-00005
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2014
• 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: SPECTRANETICS 16FR GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; 7FR COOK DILATOR SHEATH; 8.5FR COOK DILATOR SHEATH; SPECTRANETICS 14FR GLIDELIGHT LASER SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH (M/LONG); SPECTRANETICS LEAD LOCKING DEVICE EZ (TOTAL OF 2)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 64