MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Device model number, lot number, catalog number, expiration date and udi unk.Device 510k number unk because model number 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 a right atrial (ra) and a right ventricular (rv) lead due to non function.The leads had been implanted for 39 years.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Using a spectranetics glidelight laser sheath, the rv was successfully removed.During removal of the ra lead, the glidelight device advanced to the lead's proximal electrode, and then with gentle traction being provided by the lld, the lead tip freed easily and the lead was removed.The patient developed a small effusion, immediately detected with the use of transesophageal echocardiography (tee).Rescue efforts began, including pericardiocentesis and sternotomy.A right atrial appendage (raa) perforation was discovered.The repair was successful and the patient survived the procedure.This report captures the lld providing traction to the ra lead when the raa 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: 13488242
• MDR Text Key: 286877462
• Report Number: 1721279-2022-00026
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2022
• 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 6957 RV PACING LEAD; MEDTRONIC 6957J RA PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female