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 Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 01/08/2021

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove two right ventricular (rv) leads due to non function.A right atrial (ra) lead was present within the patient but was not targeted for extraction.Spectranetics lead locking devices (lld ez) were inserted into each of the rv leads to provide traction platforms to aid in lead extraction.The physician began the procedure by using a spectranetics tightrail sub-c rotating dilator sheath, but was not able to advance the tightrail sub-c device in the clavicular region.Next, the physician chose a 16f glidelight laser sheath.Shortly after the 16f glidelight device was in use, the patient's blood pressure dropped.Rescue efforts began immediately, including a rescue balloon and a right window made into the chest with a chest tube placed to drain blood.A thoracotomy was then performed, with a tear in the innominate vein identified.Repair of the tear was successful.However, more innominate tears were identified as well.Repairs were completed successfully and the patient survived the procedure (please reference mdr 1721279-2021-00012 which captures the innominate injuries which occurred while the glidelight device was in use).Neither rv lead was removed; these leads, along with the llds inside, were cut and capped and remained within the patient.The physician did not attempt to unlock the llds' within the two rv leads prior to cutting and capping them.This report captures the lld which was present within rv lead model 4068, which was cut and capped and remained in the patient.Mdr 1721279-2021-00014 captures the lld which was present within rv lead model 6947, and was also cut and capped and remained in the patient.

• 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: 11253336
• MDR Text Key: 233082587
• Report Number: 1721279-2021-00013
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)221112(10)FLP20L11A
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20L11A
• 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: 11/11/2020
• 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
• Patient Age: 55 YR
• Patient Weight: 88