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

Model Number UNKNOWN

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Perforation (2001)

Event Date 11/25/2015

Event Type  Injury  

Event Description

Lead management case to extract 2 cardiac leads.The first lead was successfully extracted using an lld and a 9f tightrail sheath.The second lead was then prepped with an lld and the physician began using a 13f tightrail sheath.During use of this device it was noted that the device handle was stuck and the physician retracted the device, noting that the device tip was not rotating.Another 13f tightrail device was then opened and again the cutting mechanism and handle became stuck.At this time the physician continued the procedure using only traction placed on the lld.A perforation of the svc occurred resulting in patient death.This is to reflect on the lld as it was the traction platform in which to extract the lead.

• 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: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 5311166
• MDR Text Key: 33932979
• Report Number: 1721279-2015-00193
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: Initial,Followup
• Report Date: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2017
• 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): Death
• Patient Age: 71 YR