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

Event Date 09/08/2023

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to bacteremia.Spectranetics lld ez lead locking devices (llds) were inserted into both leads to provide traction.Using a spectranetics 16f glidelight laser sheath on the rv lead, progress was slow and steady, encountering significant lead on lead binding at the superior vena cava (svc)/ra junction.It appeared that the rv lead''s distal coil was adhered to the bottom of the rv, causing difficulty when retracting the lead into the sheath.At this time, the patient''s blood pressure dropped, and a pericardial effusion was detected via transesophageal echocardiography (tee).Rescue efforts began, including rescue balloon, chest compressions, and sternotomy.An injury was not immediately identified, so the patient was placed on bypass.After, an upper inferior vena cava (ivc) perforation was discovered and repaired.Although the ra and rv leads were significantly scarred into the heart, both were successfully removed post-sternotomy.The patient survived the procedure in critical but stable condition.The physician stated that the rv lead was prolapsed and scarred into the ivc, which caused the perforation when traction was applied.This report captures the lld providing traction within 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

A4): patient''s weight unk.B7): other relevant history 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): great vessel 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: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 17831005
• MDR Text Key: 324432073
• Report Number: 3007284006-2023-00029
• 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: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• 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: ABBOTT 2088TC RA PACING LEAD; ABBOTT 7121 RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ IN RA LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American