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

Model Number 518-062

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

Patient Problems Unspecified Infection (1930); Perforation (2001); Scarring (2061); Tissue Damage (2104)

Event Date 01/07/2014

Event Type  Injury  

Event Description

This was a lead extraction case to remove three leads (implanted 2009) due to cied pocket infection.The first two leads (mdt 6947 sprint quattro rv icd and bsc fineline ra pacing) were prepped with llds and removed successfully with a 14f glidelight laser catheter.Due to the risk and concern over the nature of the third lead's fixation method, the patient's chest was opened prior to the extraction of this lead (mdt starfix lv pacing).The lead was prepped with an lld-ez and the 14f glidelight was used to lase down to the coronary sinus.The physician stated he applied almost 20 lbs of force over 5 minutes to the lead in order to remove it.After the lead retracted, a small tear at the cs was noticed and repaired by the ct surgeon.The physician credits the damage to the fact that the lobes of the starfix would not retract and this caused severe scarring, therefore leading to the cs perforation upon removal of the lead.The patient survived the intervention.

• 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: 3582830
• MDR Text Key: 4143149
• Report Number: 1721279-2014-00001
• 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: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2014
• 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: BOSTON SCIENTIFIC FINELINE RA PACING LEAD; SPECTRANETICS LEAD LOCKING DEVICE (LLD-EZ); SPECTRANETICS LEAD LOCKING DEVICE (LLD #2); SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; MEDTRONIC SPRINT QUATTRO 6947 RV ICD LEAD; MEDTRONIC STARFIX LV PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 107