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 Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

Patient's weight unk.Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.

Event Description

A lead extraction procedure commenced to remove two right atrial (ra) leads (one ingevity and one fineline) due to occlusion, non function and redundancy.A right ventricular (rv) lead was also present in the patient but was not targeted for extraction.Spectranetics lead locking devices were inserted into each lead to provide traction to aid in extraction.Using a spectranetics 9f tightrail sub-c rotating dilator sheath then a 12f glidelight laser sheath, the ingevity ra lead was removed with no issue.The fineline ra lead was then targeted using a spectranetics 11f tightrail sub-c rotating dilator sheath.Progression stalled, so a 14f glidelight laser sheath was then used.The glidelight device advanced to the innominate/superior vena cava (svc) junction when the lead came free and was removed.The patient's blood pressure dropped at that time and a pericardial effusion was noticed.Rescue efforts began, including a pericardial window and placement of a waynes catheter.A right atrial perforation was suspected.The intervention was successful and the patient survived the procedure.This report captures the lld which was present in the fineline ra lead when the effusion and suspected ra perforation occurred.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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 (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12397307
• MDR Text Key: 269738358
• Report Number: 1721279-2021-00167
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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?: No
• Date Manufacturer Received: 08/11/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR