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

Model Number 518-062

Device Problems Detachment Of Device Component (1104); Retraction Problem (1536)

Patient Problems Low Blood Pressure/ Hypotension (1914); Injury (2348)

Event Date 01/13/2015

Event Type  Injury  

Event Description

This was a left-sided lead extraction procedure to remove two non-functional leads.The rv lead (mdt 5076 pacing, implanted 69 months) was removed using an lld-ez and an 11f tightrail.The ra lead was prepped with an lld-ez and the 11f tightrail was used to extract, however, the helix of the ra lead did not retract.Once the physician was near the lead tip with the tightrail, the lead did not come free easily.Once it pulled free from the myocardium, the patient¿s blood pressure declined and the cts opened the chest.The injury occurred as the ra lead tip came free from the myocardium.Because the lld-ez was the traction platform being used to pull the lead free from the myocardium, this event is being attributed to the lld as the suspect device.

Manufacturer Narrative

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• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD-EZ
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: jessica hearn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4455502
• MDR Text Key: 5404322
• Report Number: 1721279-2015-00010
• 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: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• 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: 01/13/2015
• 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: MDT 5076 RV PACING LEAD (IMPL 69 MONTHS); MDT 5076 RA PACING LEAD (IMPL 69 MONTHS); SPECTRANETICS 11F TIGHTRAIL MECHANICAL SHEATH; LLD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR