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

Model Number 518-062

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/29/2021

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia and removal of an abandoned pacemaker system.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician attempted removal of the ra lead by using a spectranetics 11f tightrail sub-c rotating dilator sheath.Upon attempting removal of the lead from the device, the tightrail became stuck.It was noted that there was a piece of calcium stuck at the tip of the tightrail.The ra lead was cut and the tightrail was removed (mdr # 1721279-2021-00245).The physician was unable to unlock the lld from the ra lead since it had been cut, and both the ra lead with the lld inside were cut and capped and remained in the patient (mdr # 1721279-2021-00246).The physician then attempted to unlock the lld from the rv lead but was unsuccessful, so the rv lead with the lld inside were cut and capped and remained in the patient.There was no reported patient harm.This report captures the lld which would not unlock and was cut and capped within the rv lead and remained in the patient.

Manufacturer Narrative

A portion of the device remained in the patient and the remnant was discarded, thus no investigation could be completed.

• 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: 13014597
• MDR Text Key: 287263424
• Report Number: 1721279-2021-00247
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)231006(10)FLP21K06A
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21K06A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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: MEDTRONIC 4058M RA PACING LEAD; MEDTRONIC 5024M RV PACING LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male