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

Model Number 518-019

Device Problem Device Inoperable (1663)

Patient Problems Scar Tissue (2060); Pericardial Effusion (3271)

Event Date 12/19/2016

Event Type  Injury  

Event Description

Lead management case to extract 2 cardiac leads.The target lead was a non-functioning mdt 4024 (implanted in 1998) in the rv.The lead was prepped and an lld #2 was inserted.A 14f glidelight sheath was then utilized on the rv lead but progress stalled due to lead on lead binding in the svc.The ra lead (mdt 4524) was then prepped and another lld #2 was placed in the lead.A 14f glidelight was then utilized a second time however progress still stalled in the svc.A 13f tightrail was then selected and loaded onto the rv lead eventually freeing the lead from the area of the svc.Use of the tightrail led to successful removal of the rv lead.At time of lead tip removal, significant scar tissue was noted on the tip of the rv lead.The patient¿s vitals remained stable so the physician continued on to extract the ra lead.Upon entering the subclavian with the tightrail the lead pulled back into the subclavian.Upon removal of the ra lead a change in blood pressure was noted.A bridge occlusion balloon was immediately deployed and a pericardiocentesis was performed.The patient¿s blood pressure stabilized, the balloon was removed, a new cied system was placed and the patient was discharged to icu.No further intervention was required and the patient survived the intervention.This report will reflect on the lld as it was the traction platform used for lead removal.It is likely the effusion was caused by removal of the rv lead tip from the myocardium (as previously noted, large amount of tissue was present on lead tip).

Manufacturer Narrative

Corrected to indicate that the device is not being returned for manufacturing evaluation.This device was discarded.

Manufacturer Narrative

Follow up provided to update the device model and provide a partial udi.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 6252061
• MDR Text Key: 64909125
• Report Number: 1721279-2017-00010
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• 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: MDT 4024 CARDIAC LEAD (IMPL. 1998); MDT 4524 CARDIAC LEAD (IMPL. 1998); SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS LEAD LOCKING DEVICE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 21 YR
• Patient Weight: 70