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

Model Number 518-062

Device Problem Physical Resistance (2578)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513)

Event Date 01/09/2015

Event Type  Injury  

Event Description

Lead management case to extract 4 leads due to fracture, abandonment and total left subclavian occlusion.The physician began the case by prepping the leads, inserting lld ezs and unscrewing the helix on all four leads.Both ra leads were extracted without encountering much resistance.One of the rv leads released while the 14f glidelight laser sheath reached the ra.When the physician went to remove the other rv lead difficulty was met getting the lead to release from the rv apex, the physician then decided to attempt removal through a femoral approach but during preparation a drop in blood pressure was noted.A pericardiocentesis was performed however the drain continued pulling off fluid and the decision was made to perform a sternotomy.A hole in the rv apex was discovered and repaired.During the sternotomy the physician completed the extraction of the remaining rv lead.Two new leads were implanted, the patient survived the intervention.This is being reported on the lld since it was the traction platform in which to remove the lead and the glidelight was not in this area when the injury occurred.

Manufacturer Narrative

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• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION
• Manufacturer Contact: sondra chandler ; 9965 federal drive; colorado springs, CO 80921 ; 7194472530
• MDR Report Key: 4461269
• MDR Text Key: 5184291
• Report Number: 1721279-2015-00016
• 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: 01/15/2015

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 Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Other Device ID Number: M20451806205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 01/28/2015
• 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 LEAD LOCKING DEVICE X3; MDT 4504 CARDIAC LEAD (IMPL. 276MO); SPECTRANETICS GLIDELIGHT LASER SHEATH; MDT 4004 CARDIAC LEAD (IMPL. 276MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; CARDIAC LEAD (UNK MANUF.) X2
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR