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

Model Number 518-062

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/30/2014

Event Type  Injury  

Event Description

This was a left-sided lead extraction case to remove one mdt 4076 ra pacing lead due to high impedance ratings.An lld-ez was used to prep the lead and a 12f glidelight was used to extract.After about 2 minutes of lasing, a delayed blood pressure drop was realized and a pericardiocentesis, followed by a sternotomy, was performed.An atrial appendage tear on the free wall of the ra was discovered and repaired.The patient survived the intervention.This event is being attributed to the lld in this case as it was the traction platform being used when the lead pulled loose from the ra wall (the laser was not active when the tear occurred).

• 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: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4259980
• MDR Text Key: 18794618
• Report Number: 1721279-2014-00198
• 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: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• 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
• Other Device ID Number: PARTIAL UDI: M20451806205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• 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 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; MEDTRONIC 4076 CAPSURE FIX RA PACING (IMPL 31 MO)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 125