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 Device Embedded In Tissue or Plaque (3165)

Event Date 02/28/2023

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 model number, lot number, catalog number, expiration date, udi unk.Device 510k number unk because model number unk.A portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.Device manufacture date unk because lot number unk.Although lld cut/cap is a known risk of complication with the lld, the physician did not attempt to unlock the lld from the rv lead prior to cutting and capping.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to non function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction, and the physician chose a spectranetics 12f glidelight laser sheath to begin the case.During attempt to extract the ra lead, the glidelight was lasing within the superior vena cava and the ra lead tip pulled free.A small pericardial effusion was detected via transesophageal echocardiography (tee); an ra perforation was suspected (mdr #1721279-2023-00049).The effusion resolved without surgical intervention; however, a drain was placed to remove the blood from the pericardium.The physician chose not to remove the rv lead, and did not attempt to unlock the lld before both were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld within the rv lead which was cut and capped, and remained in the patient.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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 16518341
• MDR Text Key: 311046758
• Report Number: 1721279-2023-00050
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: BIOTRONIK SOLIA 60/60 RV PACING LEAD; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD; ST. JUDE MEDICAL 2088TC RA PACING LEAD
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Male