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

Model Number 518-062

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  Injury  

Manufacturer Narrative

A portion of the device was discarded and the other portion remained within the lead in the patient, thus no investigation could be confirmed.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and right ventricular (rv) lead due to infection.Spectranetics lead locking devices (llds) and were inserted into each lead to provide traction.Suture was also used on the leads in order to provide additional traction.The ra lead was extracted successfully.While extracting the rv lead, the physician was using a spectranetics 13f tightrail rotating dilator sheath along with wrapping both the lld and suture around his hand with a great amount of force.The rv lead and lld broke, leaving remnants of the rv lead and lld within the patient.The physician capped both the lead and lld and did not attempt any other methods of lead/lld retrieval.The patient survived the procedure.The physician believed the great amount of traction being applied caused the lld to break.This report captures the lld within the rv lead which broke and the lead/lld were 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 (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: 13343876
• MDR Text Key: 289192795
• Report Number: 1721279-2022-00011
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023076
• UDI-Public: (01)00813132023076(17)230727(10)FLP21G27A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21G27A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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
• Treatment: MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 7121 RV ICD LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SUTURE USED FOR TRACTION MANUFACTURER UNK
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American