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

Model Number 518-062

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Unspecified Infection (1930); Tissue Damage (2104)

Event Date 09/02/2014

Event Type  Injury  

Event Description

This was a lead removal case performed in the ep lab to remove four cardiac leads due to infection.The first 3 leads (sjm 1488tc-ra, 7122q-rv, and 1488tc-rv) were removed without incident.The final lead, sjm 1055k-lv, was then prepped with an lld-ez and the physician began lasing with a 12f glidelight catheter.The lv lead remained adherent to vessel wall in left ventricle, even after lasing up to os.Attempted to enter the cs using a sjm cs guide catheter to manually dissect lead from vessel wall, however, attempt was unsuccessful.Again using the 12f glidelight, they lased into the cs (although physician was reminded that the glidelight is not indicated for use in cs, physician felt there was no other choice).The physician successfully lased to distal end of lv lead without any problems; however, tip/electrode remained stuck to vessel wall.The physician then applied traction, necessary pulling was required, and lead freed and was removed.When lead released from vessel wall, it tore a small area of vessel, too.Physician noted that the lv wall border was not moving; immediately initiated rescue plan.A sternotomy was performed, the lv repaired, and the patient survived the rescue attempt.

• 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; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: linda todd ; 9965 federal drive; colorado springs, CO 80921 ; 7194472567
• MDR Report Key: 4081531
• MDR Text Key: 4900820
• Report Number: 1721279-2014-00153
• 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: 09/02/2014

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: PARTIAL UDI M20451806205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 09/11/2014
• 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: 14F GLIDELIGHT; 12F GLIDELIGHT; CVX-300 EXCIMER LASER; SJM CS GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 74