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

Model Number 518-062

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

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

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 device.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority.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.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a left ventricular (lv) lead due to non function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Attempting to remove the rv lead first, a spectranetics 13f tightrail sub-c rotating dilator sheath was used, and significant lead crossing was encountered in the innominate region.Efforts switched to remove the lv lead, which was successful using the 13f tightrail sub-c and a 13f tightrail (long).Attempting to remove the rv lead again, loss of lead integrity was noted in the innominate region.The 13f tightrail (long) was used, with adhesions discovered around the lead''s proximal icd coil, superior vena cava (svc), and halfway down the lead''s distal coil to the tip of the lead.The lead''s tip was very adhered in the rv; therefore, firm traction was applied with use of the lld, and the lead popped free.The patient''s blood pressure quickly dropped, and a quick fluoroscopy of the heart showed no movement/beating.Rescue efforts began immediately, including rescue balloon, cpr, bypass, and sternotomy.An rv perforation was discovered and repaired (mdr #1721279-2023-00074).A small, leaking perforation was found in the innominate region, which was also repaired (mdr #1721279-2023-00075).Epicardial leads were attached to the rv and lv, and a biventricular pacemaker was placed in the pocket.The patient survived the procedure.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.

• Brand Name: 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: 16931378
• MDR Text Key: 315214661
• Report Number: 1721279-2023-00074
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2023
• 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 1580 RV ICD LEAD.; SPECTRANETICS 13F TIGHTRAIL (LONG) DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS LEAD LOCKING DEVICE IN LV LEAD.; ST. JUDE MEDICAL 1156T LV LEAD.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American