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

Model Number 518-062

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2010

Event Type  Injury  

Event Description

During a lead extraction procedure on (b)(6) 2010, a laser sheath would not advance through heavy calcium, so the physician elected to cut and cap the lead with an lld-ez still inside the lead.A new atrial lead was implanted next to the abandoned lead.The patient experienced no adverse outcomes related to the lead and lld abandonment.This patient underwent another lead extraction procedure on (b)(6) 2014 and the previously abandoned lead and lld-ez were extracted successfully.It was during this procedure that a spectranetics employee became aware of the lld requiring situational abandonment in 2010.

Manufacturer Narrative

A thorough retrospective analysis of complaint data and mdr event reporting was not able to find a report for this event, therefore we are reporting at this time.

Manufacturer Narrative

Labeled for single use: yes was not checked in the first report.This follow-up report is being sent to accurately reflect this information.

• 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: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 3872443
• MDR Text Key: 4510291
• Report Number: 1721279-2014-00100
• 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: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2014
• 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 CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LASER SHEATH II; ST. JUDE MEDICAL RA LEAD (MODEL UNK, IMPL 1993)
• Patient Outcome(s): Other
• Patient Age: 67 YR