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 07/02/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth and age unavailable.The device was discarded, thus no investigation could be completed.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function (implant duration 300 months).A right atrial (ra) and a left ventricular (lv) lead were present in the patient as well, but were not targeted for extraction.A spectranetics lead locking device (lld) was inserted into the lead to provide traction to aid in extraction.The physician began by using a spectranetics glidelight laser sheath but this device failed to advance.The physician chose to use a cook medical evolution mechanical dilator sheath.During attempted lead extraction, the lead and lld broke.After several hours attempting to snare the lead and lld, they were abandoned in the patient.There was no reported patient injury.This report is being submitted to capture the lld which was providing traction to the rv lead when the lld and lead broke, and several hours of intervention to snare the lead/lld were unsuccessful.

• 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): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12242204
• MDR Text Key: 264532847
• Report Number: 1721279-2021-00142
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)230319(10)FLP21C19A
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21C19A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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): Required Intervention
• Patient Weight: 119