MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

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

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

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.

Event Description

A lead extracture commenced (b)(6) 2019 to remove a right ventricular (rv) lead due to lead failure.Spectranetics glidelight laser sheaths (14f and 16f), glidelight outer sheath and lead locking device (lld) were in use.During the procedure, the rv lead broke.They attempted to extract the tip of this lead using a snare, but were unsuccessful.The lld was removed from the rv lead and the lead was capped.On (b)(6) 2019, the patient's blood pressure dropped suddenly, and cardiac tamponade was detected.A pericardiocentesis was performed which drained 350cc and the patient became stable.No further effusion was seen at that time.On (b)(6) 2019, the team was concerned that the tricuspid valve had been damaged so the team decided to extract the rv lead surgically.A sternotomy was scheduled and performed on (b)(6) 2019.There was no injury to the right atrium nor the right ventricle of the heart.The physician attempted to remove the rv lead, but the lead tip was so deep within the rv that the physician cut the lead in front of the rv tip and the tip remained in the patient.The patient's tricuspid valve was repaired successfully.It was noted that the lead had severe adhesion with the tricuspid valve, and when the rv lead broke during the initial procedure, the team did not commence lasing with the glidelight device.There was no alleged malfunction of any spectranetics devices during the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• 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: 9345103
• MDR Text Key: 169257909
• Report Number: 1721279-2019-00199
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)210611(10)FLP19F10A
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/25/2019

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 Expiration Date: 06/11/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP19F10A
• 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
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• 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: 66 YR
• Patient Weight: 49