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

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 10/25/2019

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to lead failure.A spectranetics glidelight laser sheath and a lead locking device (lld) were in use.The glidelight device did not progress down to the right ventricle (rv) area; however the physician was able to progress with the glidelight's outer sheath and with use of the lld for traction, down to the area of the rv apex.However, the tip of the lead could not be removed due to adhesion.Counter traction, with aid of the lld, was used to continue attempts to remove rv lead tip; however, patient's blood pressure dropped.A pericardial effusion was confirmed by trans esophageal echocardiography (tee).A tear was confirmed at the rv apex, and a pericardiocentesis was performed and a temporary pacemaker was inserted.The patient was transferred to the or and the lead was removed surgically.After the lead was extracted, a new pacing lead was implanted.The patient survived 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: 9345104
• MDR Text Key: 174178032
• Report Number: 1721279-2019-00200
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)201005(10)FLP18K05A
• 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: 01/01/2005,10/28/2019

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: 10/05/2020
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLP18K05A
• 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: 10/28/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2018
• 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: 39 YR
• Patient Weight: 62