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

Model Number 518-067

Device Problem Break (1069)

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

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's date of birth, age unavailable.Patient's weight unavailable.The manufacturer is anticipating return of the device, but it has not arrived at this time.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and right ventricular (rv) lead due to non function and occlusion.The physician inserted a spectranetics lead locking device (lld) into the rv lead to act as the traction platform to aid in lead extraction.Traction was being applied to the lead with use of the lld and reportedly a hemostat clamped onto the lld when the lld broke, outside the lead.The physician knotted the broken lld together, and a spectranetics tight rail sub-c rotating dilator sheath was used to effectively remove the rv lead.Per report, the ra lead was also removed successfully, the procedure was completed and the patient survived the procedure with no reported patient harm.This report is being submitted due to the potential for serious injury if the event were to recur.The manufacturer is anticipating return of the device, but it is not available at this time.

Manufacturer Narrative

D10): device was returned to manufacturer on 04 feb 2021.H3): device evaluated by manufacturer.Device evaluation: the device was evaluated by a cross functional team on 10 feb 2021.The team determined that lld broke approximately 2 inches from the distal end of the device, which was determined by measuring the damaged device next to an intact, undamaged device of the same device model.The team observed that the device's braided mesh had been stretched and broken in multiple areas, indicating that excessive tension was placed on the device.After the lld was broken, it was reported that the physician tied the remaining part of the lld to the lead using suture (to remove the lead and distal portion of the lld) which was confirmed during device evaluation.The distal two inches of the broken lld was reportedly discarded with the lead portion.The team concluded that the tension force placed on the lld during use exceeded the device''s strength, which caused it to break.When and how the damage occurred could not be determined; however this event is determined to be use related.

• 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: 10635134
• MDR Text Key: 210002125
• Report Number: 1721279-2020-00201
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: (01)00813132023065(17)220616(10)FLK20F12A
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLK20F12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMOSTAT MANUFACTURER UNKNOWN; MEDTRONIC 6935M RV ICD LEAD; RA PACING LEAD MANUFACTURER AND MODEL UNKNOWN; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH; HEMOSTAT MANUFACTURER UNKNOWN; MEDTRONIC 6935M RV ICD LEAD; RA PACING LEAD MANUFACTURER AND MODEL UNKNOWN; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH
• Patient Outcome(s): Other