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

Model Number 518-062

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

Patient Problems Death (1802); Perforation of Vessels (2135); Iatrogenic Source (2498); Pericardial Effusion (3271)

Event Date 11/06/2020

Event Type  Death  

Manufacturer Narrative

Patient's weight unavailable.Device lot number and expiration date unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure was planned to remove right atrial (ra), right ventricular (rv) and left ventricular (lv) leads due to systemic infection.Multiple vegetations on leads were noted.Baseline intra-cardiac echocardiography (ice) was performed and confirmed vegetations.Prior to the lead extraction procedure beginning, an angiovac system was utilized from the patient's right internal jugular (ij) vein and right femoral vein.During the process of manipulating the wand in patient's inferior vena cava (ivc)/right atrium (ra), a large effusion presented on ice.The angiovac was stopped and a pericardiocentesis was performed and a drain was placed.A spectranetics lead locking device (lld) was inserted into each lead to provide traction to aid in extraction.Using a spectranetics 12f glidelight laser sheath in an attempt to remove the lv lead, progress was stalled in the innominate region.Attention was then turned to attempt removal of the ra lead.Using the 12f glidelight device and a spectranetics visisheath dilator sheath, the ra lead was successfully extracted.The 12f glidelight was again used to attempt removal of lv lead; stalled progress occurred at the coronary sinus os.A spectranetics 11f tightrail rotating dilator sheath was used on the lv lead, device actuating to the coronary sinus os and the lv lead was extracted.However, another effusion was noted approximately five minutes after the lv lead was removed.A pericardiocentesis was performed, pulling out blood and the patient was stabilized for a brief period of time before the blood pressure started to trend down.Patient experienced sinus tachycardia and poor rv and lv function.The surgeon considered opening the patient's chest at this time but decided against it because it was determined the patient would not survive this type of intervention.The anesthesiologist attempted to stabilize the patient with drug therapy and cpr was given.However, the patient's heart function did not return and the patient died on the table.This report is being submitted because an lld was present within the lv lead, acting as the traction platform; it was felt that the effusion likely had to do with the dislodgment of the lv lead and the adhesions in the coronary sinus and coronary sinus os.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: 10952180
• MDR Text Key: 219762702
• Report Number: 1721279-2020-00242
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• 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
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANGIODYNAMICS ANGIOVAC CANNULA AND CIRCUIT; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH; ST. JUDE MEDICAL 1056T LV PACING LEAD; ST. JUDE MEDICAL 2088TC RA PACING LEAD; ST. JUDE MEDICAL 7120 RV PACING LEAD
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 67 YR