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

Model Number 518-062

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/10/2015

Event Type  Injury  

Event Description

Lead management case to extract three leads.This patient presented with one lead implanted on the left side with a suspected fracture and a non-functional ppm with leads on the right.The left chest pocket was opened exposing the leads and an lld ez was advanced to the tip of the lead.A 14fr glidelight and visisheath were used.Heavy binding was noted from the subclavian vessel to the svc resulting in tremendous traction forces on the lead.The physician decided not to advance the laser into the heart and instead advanced the visisheath over the laser.Upon approaching the tricuspid valve the lead popped free from the myocardium.Initially the pressure remained steady and the laser was removed.Using the inner lumen of the visisheath the physician inserted an exchange wire and then removed the visisheath.A 10.5 fr dilator was then placed over the wire.At this point a drop in blood pressure had been noted.A sternotomy was performed revealing a 1 cm tear at the apex of the heart.The tear was sutured and the patient stabilized.Procedure was completed surgically during the sternotomy.As the glidelight and visisheath were not advanced to the rv apex this report is to reflect on the lld as the traction force; this injury was likely caused from the lead tip releasing from the myocardial tissue.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 5005546
• MDR Text Key: 23090742
• Report Number: 1721279-2015-00126
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• 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 4076 CARDIAC LEAD (IMPL. 98MO)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR