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 07/28/2022

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unk.Patient's weight unk.Relevant tests/laboratory data unk.Other relevant history unk.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.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv) and a left ventricular (lv) lead, extraction indication unk.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician used multiple spectranetics devices to attempt extraction: a 13f tightrail sub-c rotating dilator sheath, an 11f tightrail rotating dilator sheath, and 12f and 14f glidelight laser sheaths.The physician could not extract the leads, so the decision was made to cut and cap the leads until an open extraction procedure could be scheduled.The physician attempted to unlock the llds from the leads but was unsuccessful.The rv lead (mdr #1721279-2022-00157), and lv lead (mdr #1721279-2022-00158), along with the llds within, were cut and capped and remained in the patient.There was no reported patient harm.This report captures the lld present in the ra lead which was cut and capped and remained in the patient.

• 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: 15271877
• MDR Text Key: 298381514
• Report Number: 1721279-2022-00156
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)240616(10)FLP22F15A
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• 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
• Device Lot Number: FLP22F15A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2022
• 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: MEDTRONIC 4298 LV LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White