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

Model Number 518-062

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

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

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

Device lot number and expiration date are not available from the facility.The device was discarded by the user.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 lead management case commenced to remove 4 leads due to cardiac implantable electronic device (cied) pocket infection.Leads were as follows.Right atrial (ra) lead 5076-52cm, implanted: (b)(6) 2005, active.Right ventricular (rv) icd lead 6949 65cm, implanted: (b)(6) 2005, active.Right ventricular lead 5076-58cm, implanted: (b)(6) 2005, capped.Cardiac sinus (cs) lead 1458q 86cm, implanted: (b)(6) 2012, active.Spectranetics lead locking devices ez (lld) were placed down all leads.Baseline pressures were in the 90/60 range.Extraction began with the rv 6949 using a spectranetics 14fr glidelight laser sheath.After approximately 30 seconds of laser time the 6949 lead was removed.Pressures began a steady drift downward towards a low in the 50s.Rescue interventions were immediately implemented.Transesophageal echocardiogram(tee) confirmed pericardial effusion.Sternotomy was performed although once access to the heart was achieved hemostasis occurred spontaneously and no repair was necessary.The injury was not visualized, but it was suspected it was on the back of the heart in the rv.It was decided that continuing the extraction percutaneously was the best choice, so the extraction continued.All other leads were removed without incident using the 14fr glidelight.The patient was awake and responsive as of (b)(6) 2019.

• 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: 8727220
• MDR Text Key: 148970520
• Report Number: 1721279-2019-00107
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 01/01/2005,05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• 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
• Date Manufacturer Received: 05/29/2019
• 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
• Treatment: MDT ICD 5076-52 LEAD; MDT ICD 5076-58 LEAD; MDT ICD 6949 LEAD; SJM ICD 1458Q LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 109