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

Model Number 518-062

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/22/2015

Event Type  Injury  

Event Description

This was a left-sided lead extraction procedure to remove one malfunctioning atrial lead at end-of-life.The atrial lead (bsc (b)(4), implanted 165 months) was prepped with a lead locking device (lld-ez) and a 12f glidelight laser sheath was used to lase, however the sheath was unable to progress beyond the ring electrode.The physician decided to upsize to a 14f glidelight laser sheath and was able to progress to the ring (however he did not lase past the ring), freeing the tip of the lead.Shortly after the extraction of the atrial lead, the patient¿s blood pressure and pulse began to decline.The decision was made to perform a sternotomy and an injury in the ra was discovered and repaired successfully.This event is being attributed to the lld as it was the traction platform being used to pull the lead free.The physician stated that the laser sheath did not cause the injury.The injury was caused by the lead (which had grown into the atrium) as it was pulled from the myocardium.The patient survived the intervention and was doing well after the procedure.

Manufacturer Narrative

(b)(4).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: 4860211
• MDR Text Key: 5874288
• Report Number: 1721279-2015-00097
• 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: 06/22/2015

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 Expiration Date: 08/19/2016
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP14H19A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• 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; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; BSC (B)(4) RA PACING LEAD (IMPL 165 MON); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 53