MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number UNAVAILABLE

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

Patient Problems Perforation of Vessels (2135); Iatrogenic Source (2498)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

Device model number, lot number, expiration date and udi unavailable, although requested.510k number unavailable because 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), right ventricular (rv) and a left ventricular (lv) lead due to non function.Spectranetics lead locking devices were inserted in each of the three leads to act as traction platforms to aid in the leads'' extraction.According to the report, the ra and rv leads were removed without difficulty.While attempting to remove the lv lead with use of a spectranetics 16f glidelight laser sheath and the lld as traction, the physician was able to get down to the ostium of the coronary sinus and was able to pull back on the lead's blue outer insulation to successfully collapse all 4 lobes of this starfix lead.The physician kept the glidelight device outside of the coronary sinue and using gentle manual traction with aid of the lld, the lead freed.Immediately, the patient's blood pressure started dropping downward.An intracardiac echocardiography (ice) catheter confirmed an approximately 1.7mm effusion in the coronary sinus, just distal to the ostium.They immediately began cpr, performed a pericardiocentesis and were able to stabilize the patient fairly quickly.According to the philips representative present in the case, approximately 3 liters of blood was removed and returned to the patient via rapid infusion.Ice confirmed the effusion was gone and patient had stopped all bleeding within 60 minutes.The physicians felt a surgical intervention was not immediately warranted at that time due to the cessation of bleeding and to an improved/stable blood pressure.Patient was admitted to icu for overnight observation.The patient survived the procedure and according to the report, the patient was extubated the next morning.There was no alleged malfunction of any spectranetics devices in use during the procedure.This report is being submitted because the lld was used to provide traction for removal of the lv lead during the procedure, and was within the lv lead when the injury occurred.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• 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: 10385197
• MDR Text Key: 207617431
• Report Number: 1721279-2020-00169
• 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: 01/01/2005,08/03/2020

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: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• 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: 08/03/2020
• Initial Date FDA Received: 08/10/2020
• 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: 78 YR
• Patient Weight: 125