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

Model Number 518-019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Great Vessel Perforation (2152); Pericardial Effusion (3271)

Event Date 11/04/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead, leaving the right atrial (ra) and left ventricular (lv) leads in place within the patient.The physician began extraction attempt of the rv lead.A spectranetics lead locking device was inserted into the lead to provide traction.Using a spectranetics 16f glidelight laser sheath with its outer sheath, the physician encountered immediate lead to lead binding in the subclavian region.This binding caused the physician to reassess his plan and attempt to extract all leads and re-implant a new system.Physician then switched to the ra lead; inserting an lld for traction and using the same glidelight and outer sheath, the ra lead was extracted successfully.Physician then switched back to the rv lead, tip of the glidelight located in the innominate/superior vena cava (svc) junction, when the patient''s blood pressure dropped.Rescue efforts began immediately, including rescue balloon.A pericardial effusion was detected via transesophageal echocardiography (tee).Cpr performed and sternotomy followed.A pericardiocentesis was performed through the opening of the sternotomy.The patient''s heart was shocked, and the patient stabilized, along with stabilization of the effusion.To continue, the rv and lv leads were extracted post-sternotomy, and a new system was implanted.The theory was that traction pulled the lead off the svc lateral wall, bringing scar tissue and vessel tissue with it, creating a slight perforation in the svc.The rescue balloon likely tamponaded the area, allowing the vessel to clot off; no other repair was made to the svc.The patient survived the procedure.This report captures the lld providing traction to the rv lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

The device was discarded, thus no investigation could be completed.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.

• 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: 15837541
• MDR Text Key: 304091596
• Report Number: 1721279-2022-00210
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)240819(10)FLC22H17A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC22H17A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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: ABBOTT 1388T RA PACING LEAD; BOSTON SCIENTIFIC 0125 RV ICD LEAD; BOSTON SCIENTIFIC 4513 LV LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White