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 Atrial Fibrillation (1729); Iatrogenic Source (2498); Atrial Perforation (2511)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

Device lot number, expiration date unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) lead due to malfunction and occlusion.The attempted lead removal was performed on the right side of the patient.A spectranetics lead locking device (lld) was inserted into the ra lead to provide traction to aid in extraction.The physician began by using a spectranetics 14f glidelight laser sheath to attempt removal of the lead.The decision was made not to retract the helix of the ra lead to prevent it from pulling free before the glidelight device could get through the occlusion.The 14f glidelight device was used through the occlusion, in the top part of the superior vena cava (svc) because of lead on lead binding, and as the curve of the ra lead was straightening out towards the distal end of the lead.The ra lead popped free into the sheath and it was felt at the time that all was successful.However, the patient's blood pressure began to drift down and anesthesia noticed an effusion that was growing.After discussion within the team as to whether to attempt a pericardiocentesis vs.A sub-xiphoid window, ultimately the sub-xiphoid window was created.Blood was drained and the patient stabilized within five minutes of draining the blood; however, the cardiothoracic surgeon did not find a source of the bleeding.The physician then continued with the re-implantation of a new ra lead.The procedure was successful and the patient survived.In discussion after the case, the team believed the tear was probably caused by pulling the lead free of the ra and that it clotted to seal the area.No suturing was needed, as the surgical team could not find any tear.There was no alleged malfunction of any spectranetics device in use during the procedure.On (b)(6) 2021, the philips representative communicated to the manufacturer that the physician said "they are pulling the drain today.She is feeling fine.She went into atrial fibrillation, not surprising".

• 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: 11345622
• MDR Text Key: 241431054
• Report Number: 1721279-2021-00023
• 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: 01/22/2021

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: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 54