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

Model Number 518-062

Device Problem Device Inoperable (1663)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation to be submitted in a follow up mdr once completed.

Event Description

Lead management case to extract one non-functional mdt 6944 cardiac lead.The physician used a glidelight to successfully remove all adhesions along the length of the lead and applied traction at the tip of the lead.The rv lead disengaged from the myocardium and the patient's blood pressure began to drop and a pericardial effusion was noted on tee.An emergent sternotomy was performed and a 5-10mm perforation of the rv apex was found.The perforation was successfully repaired and the patient survived the intervention.It is of note that the patient's ventricular walls were very thin and easily compromised.This report is to reflect on the lld as it was inside of the cardiac lead that caused the injury and used as the traction platform for removal.

Manufacturer Narrative

This device was originally reported to be returned; however the two glidelight devices mentioned in this case were the only devices returned.These devices were evaluated and found to have no characteristics that could contribute to this adverse event.

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 EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 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: 5287776
• MDR Text Key: 33269015
• Report Number: 1721279-2015-00185
• 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,Followup
• Report Date: 11/25/2015

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 Expiration Date: 06/25/2017
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP15F25A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/17/2017
• Supplement Dates FDA Received: 01/12/2016; 03/23/2017; 08/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 41