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

Device Problem Break (1069)

Patient Problems Pleural Effusion (2010); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 08/30/2022

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Device model number, lot number, catalog number, expiration date, udi unk.Device 510k number unk because model number unk.A portion of the device was discarded, and a portion remained within the patient.Device manufacture date unk because lot number unk.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) tined lead due to non function.A spectranetics lead locking device (lld) was inserted into the lead to provide traction, but could not be inserted all the way to the distal tip, so it was locked in place in the superior vena cava (svc) region.The physician switched between a spectranetics 14f glidelight laser sheath and a spectranetics 11f tightrail sub-c rotating dilator sheath to remove the lead.The distal portion of the lead was very flimsy and there was no control, due to the lld's inability to be inserted to the lead's distal tip.While using the 14f glidelight, the physician was pulling with the lld and pushing with the glidelight and it is believed the subclavian vein was folding up like an accordion.At that time, a pleural effusion was detected.Rescue efforts began immediately, including use of a balloon and placement of a chest tube, with no further intervention required.The physician chose not to further attempt removal of the lead; therefore, he attempted to unlock the lld from the rv lead but was unsuccessful.The rv lead with the lld was cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld which was providing traction when the subclavian perforation occurred, requiring intervention, and was within the rv lead when it was 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 (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15491299
• MDR Text Key: 300651665
• Report Number: 1721279-2022-00172
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SHREE PACETRONIC 3851 RV PACING LEAD; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 127 KG