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

Model Number 518-062

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Calcium Deposits/Calcification (1758); Low Blood Pressure/ Hypotension (1914)

Event Date 03/10/2015

Event Type  Injury  

Event Description

This was a left-sided lead extraction procedure to remove two non-functional leads.The first lead, sjm 1188 rv pacing (implanted 20+ years) was prepped with an lld-ez and an 11f tightrail was used to extract.It was noted by the physician that the 20+ year old lead was tightly bound at the tip.The position of the lead was not ideal (apical and free wall).Calcification was noted throughout the procedure.After holding traction for a period of time, the lead freed itself and was removed from the body.At that time, the patient's blood pressure slowly decreased.A pericardiocentesis was performed.No further intervention was deemed necessary.Due to the age of the leads and heavy calcification, the ra lead (sjm 1388 ra pacing, also implanted 20+ years) was not extracted.The patient survived the intervention.This event is being attributed to the lld-ez as it was the traction platform being used to pull the lead free from the myocardium.

Manufacturer Narrative

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• 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: 4618744
• MDR Text Key: 20019647
• Report Number: 1721279-2015-00045
• 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: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• 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
• Date Manufacturer Received: 03/10/2015
• 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 11F TIGHTRAIL DILATOR SHEATH; SJM 1388 RA PACING LEAD (IMPL 240+ MONTHS); SJM 1188 RV PACING LEAD (IMPL 240+ MONTHS)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 50