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 Perforation of Vessels (2135); Great Vessel Perforation (2152); Pericardial Effusion (3271)

Event Date 12/01/2022

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and two right ventricular (rv) leads due to cied system/pocket infection.The ra and one of the rv leads were implanted 149 months ago; the second rv lead was implanted 17 months ago.The physician began by attempting removal of the newest rv lead, which was successfully removed by simple traction.Spectranetics lead locking devices (llds) were inserted into the older ra and rv leads to provide traction.The physician used multiple spectranetics devices (12f glidelight laser sheath with its teflon outer sheath, upsizing to a 14f glidelight and visisheath), alternating between the leads in order to progress down the vasculature.With the 14f glidelight and visisheath, advancement was made to the innominate/superior vena cava (svc) region.At that time (unk which lead was being removed), the patient''s blood pressure dropped and a pericardial effusion was noted on transesophageal echocardiography (tee).Rescue efforts began immediately, including rescue balloon and sternotomy.A non continuous perforation from the innominate to the svc/ra junction was discovered and successfully repaired.The ra and rv leads were removed post-sternotomy and the patient survived the procedure.Since the 14f glidelight and visisheath were only able to progress to the innominate/svc junction, it was likely traction that pulled the lead away from the vasculature.This event captures the lld providing traction when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk vessel and cardiac perforations are known risks of complication with use of the lld.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 ; 719447-246
• MDR Report Key: 16029949
• MDR Text Key: 305982704
• Report Number: 1721279-2022-00234
• Device Sequence Number: 1
• Product Code: DRB
• 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: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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 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: ABBOTT 2088TC RA PACING LEAD; ABBOTT 2088TC RV PACING LEAD; ABBOTT 2088TC RV PACING LEAD (IMPLANTED 17 MO); SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White