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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

Patient's age and date of birth unavailable.Device lot number and expiration date unavailable.Device manufacture date unavailable because lot number unavailable.(b)(4).

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function.A spectranetics lead locking device (lld) was inserted within the rv lead to provide traction to the lead to aid in its extraction.During the extraction, the rv lead broke and 6-10 cm of lead insulation was left behind.It was reported that the lld was removed from the rv lead in its entirety along with the inner components of the rv lead, before the rv lead remnant (insulation) was left behind in the patient's body.During re-implantation of a new lead, the patient's blood pressure dropped.Rescue efforts began immediately, including use of a rescue balloon.Under fluoroscopy it was determined that there was a right plural effusion.A sternotomy was performed and a superior vena cava (svc) injury was discovered.After examining the svc during the surgical repair, it was thought that during the re-implantation of the new rv lead, the lead perforated an area in the svc that was determined to be thin and friable, created from extraction tools used in the lead extraction.Further information obtained from the philips representative who was present during the procedure stated that although a spectranetics tightrail rotating dilator sheath was in use as well during the lead extraction, the last device in use during the lead extraction (within the area in which the perforation occurred) was a spectranetics 16f glidelight laser sheath (please reference mdr 1721279-2021-00041 which captures the event in which the glidelight was the last device in use in the area of injury).There was no alleged malfunction of any spectranetics devices in use during the procedure.This report is being submitted due to the lld providing traction to the rv lead during the procedure and the device may have caused or contributed to the lead breaking during the extraction procedure.The lead breaking with the lld inside the lead did not cause/contribute to any injury, but has the potential to do so with recurrence.

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be completed.H6): added codes 4755 and 2199.

• 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: 11567845
• MDR Text Key: 242706243
• Report Number: 1721279-2021-00042
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• Combination Product (y/n): Y
• PMA/PMN Number: K990713
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

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: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 06/06/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC 7742 RV PACING LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 77