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

Model Number UNAVAILABLE

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.Patient's weight unavailable.Device model number, lot number, expiration date and udi unavailable.Device 510k unavailable because model number unavailable.Device manufacture date unavailable because lot number unavailable.The component code and health effect impact code (heic) field was intentionally left blank.A supplemental mdr to follow upon availability to enter component code 4727 and heic code 4621.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to non function, venous occlusion and complete heart block.Both leads were implanted (b)(6) 2000; reportedly, the ra lead had failed and the rv lead was beginning to malfunction.Prior to the case, a temporary pacemaker and ice catheter were placed.Spectranetics lead locking devices (llds) were placed into each lead to provide traction to aid in extraction.In the ra lead, the ra lumen had a likely fracture present and the lld could only go halfway down the ra lead; the rv lumen was compromised and the lld could only lock to the heel (explained by the philips representative that the heel area is where the lead bends in the heart, just past the valves).The physician began the case with a spectranetics 14f glidelight laser sheath.He then used a spectranetics 11f tightrail sub-c rotating dilator sheath, then used a 16f glidelight device with a spectranetics large visisheath dilator sheath, and then finally to a 13f tightrail device.Successful extraction of the ra lead followed, and venous access was also successful.Attention was then turned to extracting the rv lead.The physician used the 16f glidelight device, then switched to a 13f tightrail device, then back to the 16f glidelight device.At that time, the rv lead was noted to have separated to a single filer.The physician was attempting to advance the glidelight device over the filer to where the insulation was intact, but the patient's blood pressure dropped.Rescue efforts began immediately, including rescue balloon and sternotomy (the surgery team was in the control room).The patient did not have to go on bypass; the bleeding in the chest was controlled as the blood pressure was stabilized.There was significant bleeding from the pocket noted as well.A tear was discovered in the superior vena cava (svc)/innominate region that had bled into the pleural space (no tamponade was visualized via transesophageal echocardiography (tee)).Repair to the tear was performed by ct surgeon and the patient was stabilized (please reference mdr 1721279-2021-00060 which captures the glidelight device which was in the area of injury when the patient's blood pressure dropped).A pacemaker was reinserted.The physician had attempted to unlock the lld from the rv lead but was unsuccessful; the rv lead, containing the lld within it, was cut, capped and abandoned within the patient.The procedure was completed and the patient survived, transferring after the procedure to ccu.This report is being submitted to capture the lld that was advanced only to the heel of the rv lead, and along with the rv lead, was cut and capped and remained in the patient.

Manufacturer Narrative

H3): a portion of the lld remained in the patient, and the remaining portion was discarded, thus no investigation could be completed.H6): added codes: 4727 and 4621.

• 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: 11671341
• MDR Text Key: 261753260
• Report Number: 1721279-2021-00061
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: S. JUDE MEDICAL 1346T RV PACING LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH; ST. JUDE MEDICAL 1388T RA PACING LEAD
• Patient Outcome(s): Other
• Patient Age: 67 YR