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

Model Number 518-062

Device Problem Mechanical Jam (2983)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 02/20/2020

Event Type  Injury  

Event Description

A lead extraction case commenced to remove a non-functional right ventricle (rv) lead.A right atrial (ra) lead was also present in the patient but was not targeted for extraction.During preparation to removed the lead, a spectranetics lead locking device (lld) was placed inside the rv lead as a traction platform.Spectranetics tightrail rotating dilator sheath was in use in the innominate region and a glidelight laser sheath was in use in the subclavian region to aid in extraction.The physician then chose to use a cook medical byrd sheath to release lead on lead binding in the superior vena cava (svc) region.At the time the physician was using the cook byrd sheath, the patient's blood pressure dropped.Rescue efforts began immediately, including rescue device and sternotomy.Perforations were identified in the superior vena cava (svc) and right atrial (ra) junction.The perforations were repaired successfully, and the patient survived the procedure.During the repair, the physician attempted to unlock and remove the lld.When the attempt to unlock the lld was unsuccessful, the lld and rv lead was cut, capped, and left within the patient's body.This report is being submitted to capture this lld device.No spectranetics devices were reported to have caused or contributed to the patient injuries mentioned above.

• 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: jessica dominguez ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9843743
• MDR Text Key: 184075656
• Report Number: 1721279-2020-00050
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023076
• UDI-Public: (01)00813132023076(17)210830(10)FLP19H28A
• 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: 01/01/2005,02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP19H28A
• 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: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2019
• 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): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 157