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

Model Number 518-062

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tissue Damage (2104)

Event Date 01/27/2015

Event Type  Injury  

Event Description

This was a left-sided lead extraction procedure to remove one medtronic starfix lv lead (implanted 59 months) due to bacteremia.The lead was prepped with an lld and a 14f glidelight laser sheath was used to extract.After 4-5 minutes of consistent traction on the lead, the patient¿s blood pressure declined.A sternotomy was performed and an injury at the coronary sinus was discovered and repaired.The physician was not able to get the ¿flaps¿ of the starfix lead to collapse and this was the main contributing factor to the injury that occurred.The patient survived the intervention and was discharged from the hospital three days after the procedure.The lld is the suspect device because it was the traction platform being used to pull the lead through the coronary sinus.The laser sheath was not used past the ostium of the coronary sinus.

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: 4595827
• MDR Text Key: 5453753
• Report Number: 1721279-2015-00039
• 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: 02/21/2015

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: PARTIAL: M2045180620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2015
• Initial Date FDA Received: 03/12/2015
• 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 STARFIX 4195 LV PACING (IMPL 59 MON); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR