MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD EZ 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 11/21/2023

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) lead due to being defective.A right ventricular (rv) lead was present within the patient but was not targeted for extraction.In addition, the subclavian vein was occluded prior to the procedure.A spectranetics lld ez lead locking device (lld ez) was inserted into the lead to provide traction.Beginning with a spectranetics 12f glidelight laser sheath and rounding the innominate/superior vena cava (svc) junction, the ra lead came loose, and was present within the svc.Then, the glidelight was left in place to maintain access for re-implantation of a new lead, and from a femoral access, a snare was used to attempt to retrieve the lead.However, after approximately 30 minutes of unsuccessful snaring attempts, the patent's blood pressure slowly decreased.A right atrial appendage (raa) effusion was detected via transesophageal echocardiography (tee), and rescue efforts began, including pericardiocentesis and sternotomy.A perforation of the raa was discovered and repaired, and the ra lead was removed.The patient survived the procedure.This report captures the lld providing traction within the ra lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

A2): patent's date of birth unk.A4): patent's weight unk.D4): device lot number, expiration date unk.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.H6): cardiac perforation is a known risk 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: LLD EZ LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 18314738
• MDR Text Key: 330327696
• Report Number: 3007284006-2023-00090
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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: BIOTRONIK SETROX 350973S/45 MM RA PACING LEAD; BIOTRONIK SETROX 350974 RV PACING LEAD; FEMORAL SNARE MANUFACTURER/TYPE UNK; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White