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 Perforation of Vessels (2135); Iatrogenic Source (2498)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

Device lot number and expiration date are not available from the facility.The device was discarded by the user.Device manufacture date is dependent on the device lot number, thus is unavailable.The device was discarded.There is no allegation of a malfunction.Therefore, no device evaluation will be performed.

Event Description

A philips representative reported that a cardiac lead management procedure commenced to extract 3 leads due to bacteremia (1 right atrial, 1 right ventricular, and 1 cardiac sinus).The first lead the electrophysiologist attempted to remove was the youngest lead which was only 11 months old) by placing the spectranetics lead locking device (lld) ez all the way to the distal tip of cs lead (about 2-3mm from tip where lead is attached) and he also prepped the other 2 leads (atrial and rv leads from 2010) by placing a lld ez in both of those leads.He then calibrated a 12 fr spectranetics glidelight laser sheath and proceeded to lase over the cs lead.The glidelight laser sheath went around of the bend of the superior vena cava (svc) and jumped slightly forward due to the tip of the cs lead popping free suddenly.Glidelight was parked just past svc when physician pulled the cs lead out and pulled the glidelight laser sheath back.At this time, the patient's blood pressure dropped very quickly to 38/30.Rescue interventions were implemented.A tear was found deep into the coronary sinus where the most distal part of lead was, where the tip of lead would possibly have been attached to tissue.The physician said that when the cs lead popped back he felt that created a small tear where the tip of lead attachment site would be.The patient was stable after rescue efforts were successful and the physician decided to continue to laser out the other 2 leads (atrial and rv leads from 2010).All leads were successfully removed.The patient remained stable and was extubated a couple hours later and discharged per protocol.The physician reported a week later that the patient recovered well and he had no further concerns.

• 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: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8972055
• MDR Text Key: 161308569
• Report Number: 1721279-2019-00157
• 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: 01/01/2005,08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• 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
• 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
• Date Manufacturer Received: 08/08/2019
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR