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

Model Number 518-062

Device Problem Break (1069)

Patient Problems Death (1802); Tissue Damage (2104)

Event Date 01/11/2016

Event Type  Death  

Event Description

Lead management case to extract one mdt 6949 cardiac lead due to cied system/pocket infection.The physician opened the pocket and prepped the lead with an lld and a cook one-tie.A 14f glidelight laser sheath was selected and lasing began maintaining traction on the lld.The laser sheath stalled on the lead and the laser was discontinued.While pulling traction the lld broke; however traction could still be held.Hemodynamic changes were noted and a sternotomy was performed.A tear in the ivc was found but the patient did not survive the intervention for repair.This report is reflecting on the lld as it was the traction platform used for the lead resulting in the tear.

Manufacturer Narrative

(b)(4).

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
• 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: 5378455
• MDR Text Key: 36338884
• Report Number: 1721279-2016-00003
• 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: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/13/2017
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP15H13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2015
• 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): Death
• Patient Age: 66 YR