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); Cardiac Perforation (2513)

Event Date 10/17/2014

Event Type  Injury  

Event Description

This was a left-sided lead extraction procedure to remove one fractured 4 year old boston scientific 0185 rv icd lead and implant of a new icd lead.The lead was prepped with an lld-ez and a 14f glidelight laser sheath was utilized for the procedure.Counter traction was used to gradually free up the lead tip from the rv.A new lead was implanted with 3-5 attempts at securing efficient pacing and defib numbers and multiple attempts to place the lead in a secure spot in the rv.Two hours post extraction, re-implant, and transfer to pacu, the patient's blood pressure declined and cpr was initiated.The patient was brought back to the or and a sternotomy was performed.A 2 cm hole in the anterior rv was found and repaired.The patient recovered from the intervention.It is possible that the implantation of the new icd lead caused the injury, however, it cannot be excluded that the extraction of the old lead may have also contributed to the injury.This event is being attributed to the lld as it was the traction platform being used to extract the lead as it was pulled free from the myocardium.

• 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: 4232277
• MDR Text Key: 19591045
• Report Number: 1721279-2014-00187
• 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: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• 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: 10/17/2014
• 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 0185 RV ICD (IMPL 48 MONTHS); SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 72