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

Model Number 518-067

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

Patient's weight is unobtainable from the site.(b)(4) selected as the adverse event and patient's death is reported in mdr 1721279-2019-00030.This mdr is being submitted to capture the malfunction of the lld only.The lld was discarded by the site.Therefore, a device evaluation cannot be conducted.

Event Description

A philips representative reported that a cardiac lead management procedure commenced.The lead extraction was being performed due to "noise" on the right ventricular (rv) lead.The operative plan was to remove the current cardiac implantable electronic device (cied) and implant a different device.The physician opened the pocket and dissected out the lead.When he took an xray image it was seen that the lead was attached from the clavicle.He then used a spectranetics lead locking device (lld) ez 518-067 which was deployed successfully.Then he used a 13fr spectranetics tightrail rotating dilator sheath.The tightrail advanced, but stopped at the clavicle.From this point, the sheath advanced slowly and with difficulty.The tightrail sheath and the outer sheath were advanced just past the superior vena cava (svc).At this point, despite putting tension on the spectranetics lld ez, the lead did not appear to straighten.At this point it was thought that the lld had slipped back from the tip of the lead.The physician attempted to further manipulate the tightrail sheath and the lld snapped.

• 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: 8388565
• MDR Text Key: 141344110
• Report Number: 1721279-2019-00031
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: 00813132023065
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 01/01/2005,02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• 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
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/04/2019
• 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): Other
• Patient Age: 62 YR