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 Problem Cardiac Perforation (2513)

Event Date 01/28/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv) and a left ventricular (lv) lead due to non function and occlusion.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The ra lead was removed successfully with no complications.Using a spectranetics glidelight laser sheath, the physician was lasing near the distal part of the lv lead, close to the coronary sinus) when the lv lead freed.They were preparing for the rv lead extraction when the patient's blood pressure dropped.A small effusion was noted via transesophageal echocardiography (tee).Rescue efforts began, including pericardiocentesis and sternotomy.A small perforation was discovered at the coronary sinus (mdr #1721279-2022-00030).The physician believed the coronary sinus perforation occurred due to traction.The repair was successful and the patient survived the procedure.The physician decided to not attempt to extract the rv lead.He did not attempt to unlock the lld within the rv lead prior to capping, so both the rv lead and lld were cut, capped and remained in the patient (mdr #1721279-2022-00031).This report captures the lld providing traction to the lv lead when the coronary sinus perforation occurred.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

The device was discarded, thus no investigation could be completed.

• 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: 13595760
• MDR Text Key: 288469266
• Report Number: 1721279-2022-00030
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023076
• UDI-Public: (01)00813132023076(17)231001(10)FLP21J30A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21J30A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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: BIOTRONIK LINOX SD RV PACING LEAD.; MEDTRONIC 5076 RA PACING LEAD.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LEAD LOCKING DEVICES.; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH.; ST. JUDE MEDICAL 1156T LV PACING LEAD.
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American