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

Model Number 518-062

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 01/30/2015

Event Type  Injury  

Event Description

This was a left-sided lead extraction procedure to remove one malfunctioning lv lead.The lead was prepped with an lld and a 14f glidelight laser sheath was used to extract.The lead came loose once the laser progressed to approximately mid-svc.Immediately, a 20 point pressure drop was noticed.A pericardiocentesis was performed and the patient's blood pressure increased.Tee confirmed 1 cm pericardial effusion and confirmed a cs injury.Surgeon and ep consulted and deemed the patient stable.The patient survived the intervention.The lld is the suspect device as it was the traction platform being used to pull the lead through the cs.

Manufacturer Narrative

Placeholder.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD-EZ
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: jessica hearn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4533201
• MDR Text Key: 5541726
• Report Number: 1721279-2015-00028
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: PARTIAL: M2045180620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2015
• 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 14F GLIDELIGHT LASER SHEATH; MEDTRONIC 4193 LV PACING LEAD (IMPL 78 MON); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 109