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 Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 04/21/2022

Event Type  Injury  

Manufacturer Narrative

Patient''s weight unk.Relevant tests/laboratory data unk.Other relevant history unk.Device lot number expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia.Spectranetics lead locking devices (llds) were inserted into the leads.Although the llds were used to provide a ''rail'' (traction applied to the lead so that the device can follow a coaxial path), a cook medical needle''s eye snare was being used from a femoral approach to attempt to extract the leads instead of being removed from the pocket.This was due to the leads being fineline models which stretch when pulled through a laser device.The physician used a spectranetics 14f glidelight laser sheath to attempt removal of the ra lead.The glidelight advanced to the superior vena cava (svc)/ra junction, and the ra lead began to stretch from the tip from being snared.The decision was made to release the snare, but the snare became entangled in the ra and rv leads.At this time, a pericardial effusion was noted on transesophageal echocardiography (tee).The effusion was not significant, and anesthesia was able to support the patient''s blood pressure and the patient was stable.The team continued with the case, freeing the snare, advancing the glidelight to remove the ra lead, then the rv lead.The effusion was increasing and the patient''s blood pressure began declining, so a pericardiocentesis was performed, followed by a pericardial window through which a clot was removed.No further intervention was required and the procedure was completed.The physician believed the needle''s eye snare most likely caused the effusion, but was unsure; an injury location was not confirmed.Later that evening, the patient arrested and went to the operating room with a hemothorax.A sternotomy was performed, and innominate and svc perforations were discovered (mdr #1721279-2022-00084).The repairs were successful and the patient survived the procedure.This report captures the lld within the ra lead providing traction which may have caused or contributed to the pericardial effusion, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: 14320152
• MDR Text Key: 293694005
• Report Number: 1721279-2022-00085
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2022
• 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: BOSTON SCIENTIFIC 4456 RV ICD LEAD; BOSTON SCIENTIFIC 4469 RA PACING LEAD; COOK MEDICAL NEEDLE'S EYE SNARE; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White