MAUDE Adverse Event Report: SPECTRANETICS CORP. SPECTRANETICS LEAD LOCKING DEVICE; DRB: LLD

Model Number 518-019

Device Problem Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/04/2015

Event Type  Injury  

Event Description

Lead management case to extract two non-functional cardiac leads.The physician prepped the 4024 with an lld #2 and attempted removal using a 12f glidelight but after progress installed an 11f tightrail was attempted.Unable to make progress the physician attempted to extract the 4524 lead by prepping with another lld and interchanging the glidelight and tightrail sheaths.Slight progress was made on this lead allowing the physician to insert two wires for lead re-implantation.At this time the physician decided not to continue the extraction leaving the llds cut and capped inside of the lead.No adverse effect has been experienced by the patient.The other lld will be reported under mdr #1721279-2015-00190.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: DRB: LLD
• Manufacturer (Section D): SPECTRANETICS CORP.; colorado springs CO
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 7194472530
• MDR Report Key: 5332282
• MDR Text Key: 35021049
• Report Number: 1721279-2015-00191
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

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: Health Professional
• Device Expiration Date: 04/13/2017
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC15D13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2015
• 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): Other
• Patient Age: 44 YR
• Patient Weight: 162