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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

Patient date of birth, age unk.Patient weight unk.Relevant history/laboratory data unk.Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non-function (fracture).The ra lead was extracted successfully.The physician used a spectranetics lead locking device (lld), inserted into the rv lead to provide traction.The lld could not advance to the distal tip of the lead due to the lead being fractured, but did reach somewhere between the proximal and distal coil of the lead.In conjunction with the lld providing traction, a cook medical bulldog lead extender was being used as well.While the lld was providing traction, it was reported that the cook bulldog device cut the high voltage cables which caused the lead to break.The lld was removed in its entirety when the portion of the rv lead was removed.A snare was attempted to retrieve the rv lead remnant but was unsuccessful, and the distal portion of the rv lead (tip and distal coil) was left within the patient with no reported patient injury.Although the cook bulldog device cut the high voltage cables and the rv lead broke, the lld was providing traction at the same time and could have contributed to the lead breaking.This report captures the lld providing traction to the rv lead, and could have contributed to the lead breaking, requiring intervention to attempt removal of the rv lead remnant.There was no alleged malfunction of any spectranetics devices in use during 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
• MDR Report Key: 12733715
• MDR Text Key: 281594233
• Report Number: 1721279-2021-00210
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH; ST. JUDE MEDICAL 1581 RV ICD LEAD; ST. JUDE MEDICAL 1688T RA PACING LEAD
• Patient Outcome(s): Required Intervention