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

Model Number UNKNOWN

Device Problems Mechanical Jam (2983); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Death (1802)

Event Date 02/17/2016

Event Type  Death  

Manufacturer Narrative

Event Description

Lead extraction procedure for non-functioning lead in the rv and ra.14fr glidelight was selected fore removal of the rv lead.Lead on lead binding was noted.A tear in the subclavian vein occurred.The ra lead extraction was attempted using a tightrail.The lead became stuck in the tightrail device.Tightrail was rotated and pulled, the distal end of the tightrail exited the insertion site.The physician cut the lead leaving half in the device and half in the patient.Pulling on the rv lead, a tear in the tricuspid valve occurred.It is believed the lead was attached to the papillary muscle, pulling on the lead tore the muscle.Repairs were done at different times.The patient was placed on bypass and underwent a tricuspid valve replacement.The subclavian vein was repaired by ir via femoral approach using a stent graft.During the valve repair, the extractor was placing her finger on the hole in the subclavian to stop bleeding.Postoperative, the patient was placed on a right ventricular assist device.The patient expired in the icu, believed due to poor surgical repair and failure of the right ventricular assist device.This report is for the lead locking device.See reports 1721279-2016-00031 for glidelight & 1721279-2016-00033 for tightrail.

Manufacturer Narrative

Correction related to mdr #1721279-2016-00033 and mdr #1721279-2016-00030.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 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: 5486979
• MDR Text Key: 39929236
• Report Number: 1721279-2016-00032
• 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: Initial,Followup,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• 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: 70 YR