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 09/14/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unk.Patient's weight unk.Patient's ethnicity/race unk.Other relevant history 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 an active right ventricular (rv) lead, a capped rv lead, and a right atrial (ra) lead due to a pocket infection.Spectranetics lead locking devices (llds) was inserted into the leads to provide traction.The physician began by using a spectranetics 11f tightrail sub-c rotating dilator sheath with all three leads, but progression stalled.He then upsized to a 13f tightrail sub-c device and further progress was made but then stalled again.A spectranetics 14f glidelight laser sheath was used on the ra and capped rv lead with progression stalling near the innominate region.Significant lead on lead binding was present during use of each of the different tools.The 13f tightrail device was then used on the capped rv lead and progress was made past the innominate and superior vena cava (svc) region.The rv lead was freed and removed from the patient's body.However, this process also caused the active rv lead to come loose from its original implanted position, and a drop in the patient's blood pressure was noted, along with a small effusion detected via transesophageal echocardiography (tee).A pericardiocentesis was performed but was unsuccessful.A subxiphoid window was made and a drain was placed in the pericardium to relieve the effusion.The blood pressure improved but remained low.A sternotomy was performed and a ra perforation was discovered, and successfully repaired with a patch.The patient survived the procedure.It was reported that all 3 leads were removed successfully during the procedure.This report captures the lld providing traction to the ra lead when the 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: 12616054
• MDR Text Key: 275952883
• Report Number: 1721279-2021-00188
• 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: 09/14/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/12/2021
• 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
• Treatment: MEDTRONIC 4024 RV PACING LEAD; MEDTRONIC 5524M RA PACING LEAD; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES IN RV LEADS; ST. JUDE MEDICAL 2088TC RV PACING LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR