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 Device Embedded In Tissue or Plaque (3165)

Event Date 10/04/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to need for icd upgrade and venous occlusion.A right atrial (ra) lead was present in the patient but was not targeted for extraction.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.The physician began by using a spectranetics 14f glidelight laser sheath.Progress stalled and the physician decided to switch to a spectranetics 11f tightrail rotating dilator sheath.The glidelight was removed from the body, and the tightrail was inserted (but never used) when the patient''s blood pressure dropped.The physician used imaging to determine location of the bleeding; however, fluid was observed near the left lung.A drain was placed within the chest and blood was removed.The patient showed pulseless electrical activity (pea), and rescue efforts began, including sternotomy.A subclavian perforation was discovered (mdr #1721279-2022-00181), requiring the surgeon to break the patient''s clavicle (collarbone) in order to access the injury.The perforation was successfully repaired.The physician and surgeon chose to leave the rv within the patient; no attempt was made to unlock the lld from the rv lead and they were cut and capped and remained in the patient (mdr #1721279-2022-00182).The patient survived the procedure.This report captures the lld present in the rv lead when it was cut, capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

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.

• 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
• MDR Report Key: 15639320
• MDR Text Key: 302163304
• Report Number: 1721279-2022-00182
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 10/04/2022
• 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: BOSTON SCIENTIFIC 4472 RA PACING LEAD; BOSTON SCIENTIFIC 4473 RV PACING LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American