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

Model Number 518-062

Device Problems Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

The device is unavailable for evaluation as it remains within the lead within the patient's anatomy.

Event Description

A philips representative reported that a cardiac lead management procedure commenced to remove a malfunctioning left ventricular (lv) lead.The physician placed the spectranetics lead locking device (lld) ez 518-062 into the lv lead and attempted to remove the lead with a spectranetics 14fr & 16fr glidelight laser sheath.After not progressing, the physician attempted to remove the lead with a spectranetics 11fr tightrail rotating dilator sheath and a spectranetics 11fr tightrail sub-c rotating dilator sheath.Unfortunately, no progress was made and the physician abandoned the lead extraction.The physician was unable to unlock the spectranetics lead locking device (lld) ez 518-062, so he cut the lld and capped the remaining lead with the lld inside.There are no plans to remove the rest of the lld and it still remains in the patient to the knowledge of the philips representative.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8251016
• MDR Text Key: 133241117
• Report Number: 1721279-2019-00006
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• 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
• Report Date: 01/01/2005,12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2019
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP17F23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2017
• 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: 69
• Patient Weight: 96