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

Model Number 518-062

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/27/2023

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove two right ventricular (rv, models 5076 and 1570) leads, and one right atrial (ra) lead due to cied system/pocket infection (pocket erosion), implanted from the left side.The patient had a right sided system (rv and left ventricular (lv) lead), which was not targeted for extraction.Spectranetics lead locking devices (llds) were inserted into each lead, along with use of suture, to provide traction.Using a 16f glidelight, the 1570 rv lead was targeted for removal.Advancement was made until the start of the superior vena cava (svc), where significant binding was noted between all three leads.The glidelight with its outer sheath was used on all three leads to attempt to progress through the binding, but attempts failed.A spectranetics tightrail 11f rotating dilator sheath was used next, and with use of the tightrail and glidelight alternating back and forth on the ra lead, advancement was made and extracted successfully.Significant lead on lead binding remained on the two rv leads.After multiple passes with the tightrail and glidelight devices alternating between the leads, advancement was achieved with the glidelight to the bottom of the right atrium while on the 5076 rv lead.Transoesophageal echocardiography (toe) showed an effusion, and the patient''s blood pressure dropped.Rescue efforts began immediately, including sternotomy.Adequate hemostasis was achieved, and a 1 cm lateral wall svc perforation was discovered and repaired (mdr #1721279-2023-00117).The physician chose not to extract the rv leads for fear of disrupting the repair.The physician attempted to unlock the llds from the leads, but was unsuccessful.The llds within the rv leads were cut and capped and remained in the patient (mdr #1721279-2023-00118 5076 rv lead, mdr #1721279-2023-00119 1570 rv lead).The patient survived the procedure.This report captures the lld within the 1570 rv lead, which was cut and capped and remained in the patient.

Manufacturer Narrative

H3): a portion of the device was discarded, and a portion remained in the patient, thus no investigation could be completed.H6): lld cut/cap 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 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: 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: 17292504
• MDR Text Key: 318800295
• Report Number: 1721279-2023-00119
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)250518(10)FLP23E16A
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP23E16A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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 1458 LV LEAD (RIGHT SIDE); MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE LDA210Q RV ICD LEAD (RIGHT SIDE); ST. JUDE MEDICAL 1570 RV ICD LEAD; SUTURE MANUFACTURER/TYPE UNK
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White