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

Model Number 518-062

Device Problems Decrease in Pressure (1490); Pressure Problem (3012)

Patient Problems Death (1802); Unspecified Infection (1930); Injury (2348)

Event Date 03/24/2014

Event Type  Death  

Event Description

Lead management case to extract one cardiac lead due to cied pocket infection.The rv lead (guidant 0095, implanted (b)(6) 1997) was prepped with an lld ez, an sls ii was used to lase to the distal rv coil where traction was applied and released to encourage freeing of the lead from the cardiac wall.Approximately 4 minutes after removal, a sudden drop in pressure was noted; tee was utilized revealing no perfusion.A medial thoracotomy was done revealing a tear in the rv apex.The injury was unable to be repaired due to a congenital pericardial hernia and the patient did not survive.

Manufacturer Narrative

This adverse event is being reported on the lld ez due to the physician using it for traction during the removal ultimately resulting in the tear, the sls ii was not advanced to the area of injury.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: sondra chandler ; 9965 federal drive; colorado springs, CO 80921 ; 7194472567
• MDR Report Key: 3705998
• MDR Text Key: 17386985
• Report Number: 1721279-2014-00051
• 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
• Report Date: 03/24/2014

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: 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
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 03/27/2014
• 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 16F LASER SHEATH II; BOSTON SCIENTIFIC GUIDANT 0095 (IMPL. (B)(6) 1997); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Death
• Patient Age: 50 YR