MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD #2

Model Number 518-019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946)

Event Date 08/13/2015

Event Type  Injury  

Event Description

Lead management case to extract one non-functional bsc 0184 cardiac lead.The physician prepped the lead with an lld and began lasing with a 14f glidelight.Progress stalled and the device was upsized to a 16f glidelight.While the laser sheath was in the ra the lead release from the rv.A drop in bp was noted and upon visualization on tee a tear was identified on the tricuspid valve leaflet.The patient was stabilized with medication and transported to icu for observation.No additional treatments were required and the patient was discharged.Upon visual inspection of the icd lead, a significant amount of tissue was found attached to the lead along with extruded cables.The physician believes the primary cause of the tear was due to lead insulation and conductor cables pulling free from the leaflet during removal.The glidelights involved in this case were not in use near the tricuspid valve.This report is to reflect on the lld as it was the traction platform in use during lead removal.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD #2
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 5069565
• MDR Text Key: 25482977
• Report Number: 1721279-2015-00141
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/13/2015

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 Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: UNKNOWN
• Other Device ID Number: PARTIAL: 00813132020767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 56