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

Model Number	518-067
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8388565
• Report Number: 1721279-2019-00031
• Device Sequence Number: 2242146
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: 00813132023065
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K142116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2019
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005