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 Iatrogenic Source (2498); Atrial Perforation (2511)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Patient weight unavailable.Device lot number and expiration date unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to rv lead malfunction and due to patient's ejection fraction (ef) being >70%, it was thought that if the leads were removed, that the patient might not any longer need them.Spectranetics lead locking devices (lld's) were placed within each lead to provide traction during lead removal.The case began with the surgeon using a spectranetics 14f glidelight laser sheath to extract the ra lead; ultimately the ra lead released, retracted into the glidelight's sheath, and was removed.Significant scarring was noted around this lead, resembling a ''sleeve'' of scar tissue (both ra and rv leads were implanted (b)(6) 2010).However, while calibrating a 16f glidelight device to begin working on the rv lead, transesophageal echocardiography (tee) revealed a growing effusion.The surgeon was scrubbed in for the case and performed a partial sternotomy in hope that a full sternotomy wouldn't be needed, since the effusion stopped growing.However, the decision was made to perform a full sternotomy and a perforation of the ra was noted.Repair to the area was successfully made.From the pocket (and while the chest remained open), a 16f glidelight device was used to attempt to free the rv lead; however progress stalled in the subclavian region due to significant scarring.The physician then chose a spectranetics 13f tightrail sub-c rotating dilator sheath that successfully made it to the innominate region.However, the surgeon noted bleeding from the patient's chest and an innominate injury was quickly discovered.The tightrail sub-c was removed.It was a difficult repair; it was determined that the patient's saphenous vein would not work for repair, so the area was repaired using bovine pericardium.At that point, the team chose not to remove the rv lead, with the thought that there would likely be additional scarring down the rv lead.The rv lead (with the lld remaining inside the lead) was cut and capped and left within the patient.The physician did not attempt to unlock the lld in the rv lead prior to cutting and capping.After the procedure, there was concern as to whether or not the bovine pericardium patch was holding; the patient was transferred while on extracorporeal membrane oxygenation (ecmo) to a larger facility in san francisco for further follow up.The patient ultimately died on (b)(6) 2020.This report captures the ra perforation that occurred when the lld was providing traction within the ra lead.Mdr 1721279-2020-00236 captures the innominate injury which occurred during use of the spectranetics tightrail device along with the patient's death, occurring 2 days post procedure, and mdr 1721279-2020-00237 captures the lld which was present in the rv lead and was cut and capped and remained in the patient.There was no alleged malfunction of any spectranetics device 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 Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10878458
• MDR Text Key: 217925741
• Report Number: 1721279-2020-00235
• 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: 10/28/2020

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 Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2020
• 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: 72 YR