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 Problem Cardiac Perforation (2513)

Event Date 01/31/2022

Event Type  Injury  

Manufacturer Narrative

Device model number, lot number, catalog number, expiration date, udi unk.Device 510k number unk because model number unk.Device manufacture date unk because lot number unk.

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 cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Ra and rv leads were removed successfully.Lastly, the lv lead was removed with a spectranetics 12f glidelight laser sheath and the lld within the lead providing traction.Five minutes following removal of the lv lead, the patient's blood pressure steadily declined.Rescue efforts began, and a sternotomy was performed, revealing a posterior coronary sinus perforation.Repair to the perforation was successful, and the patient survived the procedure.This report captures the lld providing traction to the lv lead when the coronary sinus perforation occurred, requiring intervention.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: 13600804
• MDR Text Key: 286877203
• Report Number: 1721279-2022-00033
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• 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: 01/31/2022
• 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 4195 LV PACING LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White