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

Model Number 518-067

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

Patient Problems Iatrogenic Source (2498); Cardiac Perforation (2513)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.Patient's weight unavailable.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead to upgrade for an mri.Both of the leads were implanted in (b)(6) 2011.Spectranetics lead locking devices (lld's) were inserted into each lead to provide traction to aid in the lead's extractions.Beginning with a spectranetics 14f glidelight laser sheath, the physician first attempted to remove the rv lead.However, the lead was stuck around the distal lead coil present in the ra.Efforts were then switched to extract the ra lead using a 12f glidelight device, but the lead was stuck in the innominate vein.Countertraction was then applied to the ra lead and it was removed successfully.Efforts were focused again on removal of the rv lead.Progress was made to around the tip of the rv lead, but then was stuck again.Noting that the rv lead was expanded, a 16f glidelight device was used.Countertraction could not be used at this time due to the adhesions present.They tried to remove adhesions using a femoral snare, and then lasing the adhesions.Finally, they removed the rv lead successfully but the patient's blood pressure dropped and cardiac tamponade was noted on transesophageal echocardiography (tee).Rescue efforts began immediately, including drainage.The patient's blood pressure temporarily recovered and then dropped again.At that time, a sternotomy was performed and an injury was confirmed at the rv apex.Repair to the area was successful, the patient survived the procedure and was transferred to icu.Although the blood pressure dropped after the femoral snare was used and lasing occurred, the lld was present within the rv lead providing traction during the procedure, and it cannot be determined if this device could have caused or contributed to the rv perforation that was discovered.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: 11387401
• MDR Text Key: 240381471
• Report Number: 1721279-2021-00025
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)220909(10)FLP20J01A
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2022
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLP20J01A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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: 33 YR