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

Model Number 518-062

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Low Blood Pressure/ Hypotension (1914); Excessive Tear Production (2235)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

Date of birth unavailable from facility.Patient weight unavailable from facility.Device lot number/expiration date unavailable from facility.

Event Description

A (b)(6) female patient having lead extraction procedure.The physician prepped the lead with an lld ez device, debrided the generator pocket and gave the lead minimal traction.They quickly noticed a blood pressure drop.Rescue efforts commenced; patient stabilized for a period of time.The decision was made to remove the lead.The physician used a 14fr glidelight laser sheath in addition to the lld in place within the lead, and was able to advance the glidelight to the lead tip without ever activating the laser.The lead came free and was removed.However, the patient's blood pressure again dropped; it was determined that the injury was to the ra/ivc junction.Rescue efforts commenced; a sternotomy was performed, tear was repaired, and patient survived the procedure and interventions.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: jason hearn ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-236
• MDR Report Key: 6639988
• MDR Text Key: 77535063
• Report Number: 1721279-2017-00112
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• 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: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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; SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 42 YR