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

Model Number	518-039
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable.Patient's sex unavailable.Patient's weight unavailable.
Event or Problem Description
This report was received from a distributor in (b)(4): a lead extraction procedure commenced; it is unknown to the manufacturer how many leads, the location of the leads or the indication for extraction.It was reported that a spectranetics lead locking device was chosen to provide a traction platform for the lead, but the lld did not progress to the distal tip of the lead.The physician used the guide wire for the pacemaker to insert the lld within the lead.Using a spectranetics 9f tightrail rotating dilator sheath, it was reported that the physician could not get through the calcification that was present within the vessel, in the subclavian region.The manufacturer became aware on 14 april 2020 that the lead and lld reportedly broke at some point during the procedure, and the lead with a portion of the lld inside the lead were cut, capped, and remained within the patient's body.The case was postponed; the patient survived the procedure.This report is being submitted to capture the lld which broke along with the lead, and the lead/lld cut, capped, and remained within the patient's body.

• 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: 10022741
• Report Number: 1721279-2020-00104
• Device Sequence Number: 2501935
• Product Code: DRB
• UDI-Device Identifier: 00813132023058
• UDI-Public: (01)00813132023058(17)210603(10)FLJ19E30A
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K043401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2021
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: FLJ19E30A
• 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: 04/14/2020
• Initial Report FDA Received Date: 05/04/2020
• 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: Required Intervention
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005