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

Model Number 518-019

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/10/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv), a right atrial (ra) and a left ventricular (lv) lead due to bacteremia, and cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Using a spectranetics 16f glidelight laser sheath, the rv lead was successfully removed.While attempting removal of the ra lead and with the glidelight in the svc region, the ra lead released with traction.The patient''s condition declined and rescue efforts began, including bypass and sternotomy.An ra perforation was discovered (mdr 1721279-2022-00187) and was successfully repaired.The atrial wall was very thin and it was thought that due to the ra lead being a fixed screw lead, the damage was caused when traction was applied and the ra tip released.The physician did not remove the ra or lv leads and did not attempt to unlock the llds from the leads; both leads and llds were cut and capped and remained in the patient.The patient was transferred to the icu in critical condition; however, on (b)(6) 2022 the patient died.This report captures the lld in the lv 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.Although the patient died, the lld present in the lv lead did not cause or contribute to the patient''s death.

Manufacturer Narrative

A portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.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: 15731122
• MDR Text Key: 303045302
• Report Number: 1721279-2022-00186
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023014
• UDI-Public: (01)20813132023014(17)240621(10)FLC22F15A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC22F15A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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 0184 RV PACING LEAD; BOSTON SCIENTIFIC 4469 RA PACING LEAD; BOSTON SCIENTIFIC 4524 LV LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White