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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 01/01/2013

Event Type  Injury  

Event Description

Lead management case to extract one rv lead due to cied system/pocket infection.The lead was extracted using an sls and lld seemingly without difficulty.The patient was discharged to recovery; while in recovery the patient status declined.Post ¿op images revealed a small effusion in the rv.The perforation was repairable and discussed with the patient¿s family.Due to the patient¿s age and current quality of life the family opted not to have the perforation repaired and the patient did not survive.This event is being reported on the lld as it was used as the traction platform for lead removal; the nature of the injury indicates that it occurred when the lead released from the myocardial wall.

Manufacturer Narrative

The date of this procedure was approximately 2 years ago from the physician's account; the date of (b)(6) 2013 is an estimation and not the actual date of the procedure.Additional details are not known or available from the facility/physician since the date of the procedure is unknown, staff changes that have occurred and physician uncertainty.Placeholder.

• 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 CORPORATION
• Manufacturer Contact: sondra chandler ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 4703285
• MDR Text Key: 5644349
• Report Number: 1721279-2015-00064
• 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: 03/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• 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: 03/28/2015
• 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; SPECTRANETICS LASER SHEATH II
• Patient Outcome(s): Death