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 12/08/2021

Event Type  Injury  

Manufacturer Narrative

Patient's weight unk.The device was discarded, thus no investigation could be completed.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.A spectranetics 16f glidelight laser sheath was calibrated and used in the patient for a few seconds.An area on the device was observed to be knotted/kinked (kink could have occurred during handling of the device during calibration).The device's laser fibers became apparent through that knotted/kinked area with just a few seconds of lasing (mdr #1721279-2021-00256).The device was discarded; another glidelight device was opened and used.However, after several attempts with different tools including snaring from the groin, the rv and ra leads, with llds present within each lead, were cut and capped and remained in the patient (mdr #1721279-2021-00258 lld in ra lead).The physician did not attempt to unlock the llds from the leads prior to cutting and capping.The patient survived the procedure.This report captures the lld which remained in the rv lead when it was cut/capped by the physician.There was no alleged malfunction of the llds used in 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: 13120221
• MDR Text Key: 283086309
• Report Number: 1721279-2021-00257
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023014
• UDI-Public: (01)00813132023014(17)230716(10)FLC21G14A
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2023
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC21G14A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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 0185 RV ICD LEAD.; BOSTON SCIENTIFIC 4470 RA PACING LEAD.; FEMORAL SNARE MANUFACTURER UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATHS.; SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD.; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH.
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White