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

Model Number 518-019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Iatrogenic Source (2498); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

Patient age and weight were unavailable from the physician.Device model number, lot number, unique device identifier, and expiration date are not available from the facility.The device was discarded by the user.Device 510k cannot be determined without the model#.Device manufacture date is dependent on the device lot number, thus is unavailable.The device was discarded.There is no allegation of a malfunction.Therefore, no device evaluation will be performed.

Event Description

A philips representative reported that a cardiac lead management procedure commenced due to bacteremia and cardiac implantable electronic device (cied) pocket infection.The physician utilized the spectranetics sls laser sheath and spectranetics lead locking device (lld) to remove the right ventricular (rv) pacing lead.He stopped 1.5 cm before the end of the tip of the lead where there was still tissue to be removed.He applied gentle traction to the lld, keeping the sls laser sheath in place, but without activating the spectranetics cvx-300 excimer laser system foot switch.After 30 seconds the lead came out with a small peace of pericardial tissue of about 2 mm visible on the tip of the lld.The transesophageal echocardiogram (tee) showed a pericardial effusion.Rescue interventions were implemented and successful.The patient was brought back to a stable state and was discharged a few days later.

Manufacturer Narrative

Device model#, lot#, di # and expiration date now provided.Model numbers of pacing leads provided.510k now provided.Device manufactured date now provided.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8386464
• MDR Text Key: 137697641
• Report Number: 1721279-2019-00027
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• PMA/PMN Number: K990713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2020
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC18K04A
• Was Device Available for Evaluation?: No
• 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: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOTRONIK AROX 60BP LEAD.; BIOTRONIK SELOX SR53.; PACING LEAD (MFR UNKNOWN).; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS SLS LASER SHEATH.; PACING LEAD (MFR UNKNOWN); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS SLS LASER SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention