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 Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.Patient's weight unavailable.(b)(4).

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) lead that was fractured.A right ventricular (rv) lead was also present within the patient but was not targeted for extraction.The procedure was a right sided extraction.A spectranetics lead locking device was inserted into the ra lead to provide traction to aid in the lead's extraction.Then the plan was to use a spectranetics 11f tightrail mini rotating dilator sheath to begin the procedure, and then use a laser device to continue the extraction.However, when using the tightrail, the physician advanced the tightrail just 4 clicks and pulled to device out of the body because the lead had started to come up into the subclavian region.With use of the lld for traction, the lead pulled out the rest of the way.However, the patient's blood pressure dropped and an effusion was noted.Rescue efforts began, including a rescue balloon.It is believed by the team that the area of the heart which affected the drop in blood pressure had clotted, because the blood pressure went back to stable.However, the cardiothoracic surgeon made a pericardial window and repair was completed of a very small hole discovered in the right atrium.Repair was successful and the patient survived the procedure.The physician believes that the screw on the distal tip of the lead had remained in the wall of the right atrium and kept stretching during traction, which may have caused the small hole.There was no alleged malfunction of any spectranetics device in use during the procedure.

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be completed.H6): added codes: 4755, 4619, and 4621.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11779748
• MDR Text Key: 264409103
• Report Number: 1721279-2021-00076
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)230211(10)FLP21B10A
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21B10A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR