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

Model Number UNKNOWN

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

Patient Problems Bradycardia (1751); Iatrogenic Source (2498); Pericardial Effusion (3271)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

Device model number, lot number, expiration date and udi unavailable.510k number unavailable because device model number unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove three leads: a right atrial (ra) lead, a right ventricular (rv) lead and a left ventricular (lv) lead due to infection.Each lead was prepped with a spectranetics lead locking device (lld) to provide traction.The physician began by using a 16f glidelight laser sheath and successfully extracted the rv and ra leads.The team performed a coronary sinus (cs) venogram and then proceeded to remove the lv lead using 12f and 16f glidelight devices.The procedure was then completed, with the patient closed and extubated.However, shortly afterward, the patient's heart rate dropped and rescue efforts commenced immediately, including cpr.The patient was re-intubated and a pericardiocentesis was performed, removing a total of 350cc fluid.The patient survived the procedure, and was transferred to the cardiac icu.The patient's chest was never opened; the pericardiocentesis was the only intervention to treat the effusion.The physician believed that as a result of traction in the coronary sinus, an injury occurred, likely in the coronary sinus.Injury location was never confirmed.

• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9696002
• MDR Text Key: 180209952
• Report Number: 1721279-2020-00032
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 01/01/2005,01/15/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNAVAILABLE FROM FACILITY
• 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
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/11/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 115