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

Model Number 518-062

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/02/2014

Event Type  Injury  

Event Description

Lead management case to remove 1 lead due to lead fracture.The lead was prepped using an lld and lasing was done using a 14f and then a 16f glidelight.Upon removal of the lead a drop in blood pressure was observed.Upon checking fluoroscopy and ultrasound images blood was noticed to be pooling in the pericardial space.A pericardiocentesis was performed and the patient stabilized without further incident.The exact etiology of the patient's decline could not be determined; however the physician speculated that the decline was caused by a small self-healing perforation of the rv apex.This type of injury is most likely caused by the release of the lead from the cardiac wall at place of implantation.Due to the lld being used as a traction platform to release the lead from the cardiac wall, this report is being made to reflect on the lld.No injury could be found on subsequent imaging studies.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: sondra chandler rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472530
• MDR Report Key: 3962105
• MDR Text Key: 4555293
• Report Number: 1721279-2014-00122
• 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,Followup
• Report Date: 07/02/2014

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: 09/16/2014
• Initial Date FDA Received: 07/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/19/2014
• 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: SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 75