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

Model Number 518-062

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Calcium Deposits/Calcification (1758); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 06/05/2015

Event Type  Injury  

Event Description

This was a left and right-sided lead extraction procedure to remove three cardiac leads due to bacteremia using a glidelight laser sheath, tightrail mechanical dilator, and visisheath.Lead locking devices (llds) were used to prep the leads.The glidelight, tightrail, and visisheath were not able to get through the highly calcified vasculature, but the physician was able to use manual traction to pull the sjm 1348t rv pacing lead free.Upon extraction, the patient became hypotensive.A sternotomy was performed and an rv apex perforation was found and repaired.The remaining two leads were removed during the open procedure.The patient survived the intervention.This event is being attributed to the lld as it was the traction platform used to pull the lead free from the myocardium.

Manufacturer Narrative

Placeholder.

• 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
• Manufacturer Contact: jessica hearn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4837969
• MDR Text Key: 5944686
• Report Number: 1721279-2015-00093
• 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: 06/05/2015

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
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 06/11/2015
• 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: SJM 1342T RA PACING LEAD (IMPL 67 MON); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SJM 1348T RV PACING LEAD (IMPL 67 MON); SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICE X 2; SJM 330-258 RV PACING LEAD (IMPL 278 MON)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 54 YR