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

Model Number	518-022
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device lot# could not be provided as the device was discarded and the # was not recorded.Device expiration date is determined by the lot# and therefore unavailable.Device manufactured date is determined by the lot# and therefore unavailable.Device remains within patient.Therefore, no device evaluation will be performed.Instructions for use for this device state: warning: excessive applied traction forces may impact the lld¿s ability to disengage from a lead.
Event or Problem Description
A philips representative reported that during a lead management procedure to remove a non-functional right ventricular implantable cardioverter defibrillator (icd) lead a spectranetics lead locking device #2 (lld) 518-022 was utilized.Throughout the procedure the blood pressure dropped and recovered several times.The physician would relax his traction and the blood pressure would recover.It appeared the pressure drop was due to the inversion of the right ventricle (rv) while applying tension on the lead with the lld.The patient's blood pressure dropped again, but did not recover and rescue interventions were required (see mdr 1721279-2019-00060 which covers the device in use during this part of the procedure as well as patient injury).The lead locking device was cut and capped within the lead.This mdr is being submitted to capture the lld cut and cap within the patient.

• 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: 8466110
• Report Number: 1721279-2019-00061
• Device Sequence Number: 1341454
• Product Code: DRB
• UDI-Device Identifier: 00813132023027
• UDI-Public: 00813132023027
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K990713
• 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): 03/13/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 518-022
• Device Catalogue Number: 518-022
• 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: 03/13/2019
• Initial Report FDA Received Date: 03/29/2019
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 63
• Date Report Sent to FDA: 01/01/2005