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

Model Number 518-067

Device Problem Difficult to Remove (1528)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 08/26/2014

Event Type  Injury  

Event Description

This was a lead extraction case performed in the operating room to extract a sjm 2088tc brady lead from the ra.The lead was prepped with an lld-ez, and a 12f glidelight was initially used.The 12f glidelight was removed and traction was applied to the lld-ez to remove the lead.Upon removal, there was a drop in pressure from 101/55 to 83/48 and also a development of a small effusion (noticed by anesthesia).The injury occurred when the lead tip was extracted from the ra after applying substantial traction/counter traction.Pressure never dropped below 80/45 and the effusion was growing very slow.After watching echo for 20 minutes, the physician decided to do a pericardial window.Examination of the lead tip showed a small amount of tissue which was thought to have caused the effusion.Patient tolerated the procedure and was released.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD-EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: linda todd ; 9965 federal drive; colorado springs, CO 80921 ; 7194472567
• MDR Report Key: 4071647
• MDR Text Key: 16856972
• Report Number: 1721279-2014-00140
• 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: 08/26/2014

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: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: UNKNOWN
• Other Device ID Number: PARTIAL UDI M2045180670A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 09/09/2014
• 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: CVX-300 EXCIMER LASER; 12F GLIDELIGHT
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR