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 02/28/2024

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and two right ventricular (rv, models 7120 and 6947) leads due to non function, and a redundant rv lead.Spectranetics lld ez lead locking devices (lld ezs) were inserted into the ra and 6947 rv lead, but could not be inserted into the 7120 rv lead any further than the clavicle.It was hoped that by removing the ra and 6947 rv leads, it would free up the 7120 rv lead to be able to insert an lld within the lumen.Beginning with a spectranetics 11f tightrail sub-c rotating dilator sheath (due to the presence of calcium in the pocket) and alternating between the ra and 6947 rv leads, advancement was made to the innominate/superior vena cava (svc) junction.Next, a spectranetics 11f tightrail (long) was used on the ra lead.Progress was made to approximately 10 cm from the lead's distal tip then stalled, and either the tissue or lead insulation appeared to be snow plowing (bunching up on the lead).Efforts switched to the 6947 rv lead with the same 11f tightrail (long), and advanced to the middle of the lead's distal coil.Then, a 13f tightrail (long) was used on the ra lead, and extraction was successful.Using the same 13f tightrail on the 6947 rv lead, progress was made 1-2 cm from the lead's distal tip, and then, with traction only, the lead released.However, a small pericardial effusion was detected via transesophageal echocardiography (tee), and the patent's blood pressure dropped.Rescue efforts began, including chest compressions, sternotomy, bypass and ecmo.A 1 cm perforation in the rv apex was discovered and repaired.At that time, it was decided that the 7120 rv lead would not be extracted.The patient survived the procedure.This report captures the lld ez providing traction within the 6947 rv lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date 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: 18998917
• MDR Text Key: 338885980
• Report Number: 3007284006-2024-00062
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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 7120 RV ICD LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS LLD EZ IN RA LEAD; SPECTRANETICS TIGHTRAIL 11F DILATOR SHEATH; SPECTRANETICS TIGHTRAIL 13F DILATOR SHEATH; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White