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

Model Number 518-062

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Patient date of birth and age unavailable.Patient weight unavailable.

Event Description

It was reported that a lead extraction procedure commenced to remove two leads: a right ventricular (rv) lead and a right atrial (ra) lead due to non function (these two leads were implanted 11 years).A second ra lead was present within the patient, but not initially targeted for extraction, implanted 1 year.It was noted that the older leads were fractured and had insulation damage prior to the procedure; this damage to these leads made lead removal difficult.A spectranetics lead locking device (lld) was placed within the rv lead to act as the lead's traction platform.A spectranetics 9f tightrail rotating dilator sheath was also chosen to aid in the rv lead's removal.During the procedure, the physician chose to upsize to a larger tightrail device.However, after the 9f tightrail was removed from the patient's body, it was reported the lld became stuck inside the tightrail device.The physician could advance the tightrail towards the patient, but when attempting to remove the tightrail from the lld at a certain point while outside the patient's body, it was reportedly stuck.It was unclear why the lld became stuck, but it was thought to be due to the insulation failure of the rv lead.At that point, the physician pulled on the lld and it broke, just above the device's waveform that keeps the device's mandrel (locking mechanism) in place.The remaining lld portion was able to be secured with suture to then successfully complete the rv lead's removal, along with use of another tightrail device.The younger ra lead (implanted for 1 year) that was initially not targeted for extraction, was ultimately removed to make the lead removal easier, due to the complexity of the extraction, removed by traction only.The older ra lead was also successfully removed without complication.The patient survived the procedure with no reported patient harm.This report is being submitted due to the potential for serious injury/death with recurrence, if an lld broke within a 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 Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10818814
• MDR Text Key: 228031793
• Report Number: 1721279-2020-00227
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)220224(10)FLP20B22A
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20B22A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2020
• 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
• Patient Outcome(s): Other