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

Model Number 518-062

Device Problems Pacing Problem (1439); Retraction Problem (1536); Cut In Material (2454); Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Tissue Damage (2104); Low Pulmonary Arterial Wedge Pressure (2479); Pericardial Effusion (3271)

Event Date 04/22/2016

Event Type  Injury  

Event Description

This was a procedure to replace a right atrial lead due to its inability to pace effectively.Once the pacer pocket was opened, it was appreciated that the insulation on the ra lead was severely compromised.The ra leads helix was retracted, the terminal pic cut off and an ez lld was place to the tip.A 12 fr glide light laser sheath was used to ablate the scar between the ra and rv leads to the right atrium.Once the laser was advanced to the ra the sheath was advanced to the ra tip.The physician attempted to dislodge the ra tip with appropriate counter traction without release of the lead.Due to this the physician requested the ct surgeon for consultation.Counter traction was again applied to the ra lead, which released it from the heart.Approximately five minutes after the lead extraction the patient arterial pressure was sagging and in the 60's.A tee showed a pericardial effusion, the ct surgeon returned and performed a pericardiocentesis which returned approximately 80 cc's of blood.The patient's pressure stabilized but failed to return to normal.The surgeon performed a sternotomy to repair an injury to the patients ra.It was sutured closed.The injury was reported to be round holes which appeared to be the size of the ra lead tip.It was theorized by the physician that the lead had perforated the ra at time of implant, 62 months earlier.The patient survived the procedure and was taken to icu.Her current status is good.This report is against the lld as it was the mechanism of traction.

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; 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: 5659736
• MDR Text Key: 45312174
• Report Number: 1721279-2016-00064
• 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: Initial,Followup,Followup
• Report Date: 04/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 62