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)

Event Date 05/29/2020

Event Type  Death  

Manufacturer Narrative

Patient weight unavailable.Device lot number, expiration date 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 left ventricular (lv) lead due to cied system/pocket infection.The rep present at the procedure stated the leads had to come out due to the infection.Spectranetics lead locking devices (lld's) were inserted in each lead to act as traction platforms to aid in lead extraction.A spectranetics 11f tightrail rotating dilator sheath was used to successfully remove the rv and ra leads; the lv lead was left to extract last because the team anticipated that the type of lv lead (starfix) was likely to be extremely difficult to remove.Using the tightrail device, the physician freed up the lv lead all the way to the coronary sinus (cs) opening (os) but could not get the lobes of the lv lead to retract back.It was reported that using the tightrail and traction, it appeared that the coronary sinus was inverting on itself, and was difficult to tell at times where the tightrail device was located within the vasculature.While the tightrail was in use near the area of the cs os, the patient's blood pressure dropped.The surgeon performed a subxyphoid window and drained the pericardium, and the patient's blood pressure stabilized, but the lv lead and the lld within the lead remained.The physician then removed the tightrail device, and began to work from a femoral access to remove the lv lead with a snare.During snaring, the patient's blood pressure dropped even further.Rescue efforts commenced, including sternotomy and bypass.The physician felt that an initial injury was created near the cs os, involving the tightrail device (please refer to mdr #1721279-2020-00125 which captures this initial injury), and while snaring, there was either an extension of the same injury near the cs os, or in another location within the cs.This report captures the lld which remained within the lv lead and was present within the lv lead while snaring was occurring, and while the patient's blood pressure dropped the second time, necessitating sternotomy.The physician successfully repaired the injury but unfortunately, the patient coded and died two days later on (b)(6) 2020.

• 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: 10157641
• MDR Text Key: 195245691
• Report Number: 1721279-2020-00124
• 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: 01/01/2005,05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• 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
• 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: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 4076 RA PACING LEAD; MEDTRONIC 4195 LV PACING LEAD; MEDTRONIC 6947 RV PACING LEAD; SNARE MANUFACTURER UNKNOWN; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Death
• Patient Age: 74 YR