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

Model Number 518-062

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

Patient Problems Perforation of Vessels (2135); Great Vessel Perforation (2152)

Event Date 03/20/2023

Event Type  Death  

Manufacturer Narrative

Patient's date of birth, weight, relevant test/ laboratory data & other relevant history unknown.Device lot number, expiration date unknown.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unknown.Adverse event problem: vessel perforations are known risks 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.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to malfunction.The patient had a right atrial (ra) and an active left ventricular (lv), both not initially targeted for extraction.However, an abandoned lv lead was discovered within the patient and was targeted for removal as well.Spectranetics lead locking devices (llds) were inserted into the rv and abandoned lv leads to provide traction; however the lld used within the abandoned lv lead did not reach the lead's distal tip.A spectranetics 16f glidelight device was used to attempt extraction of the rv lead, but advancement was unsuccessful.A spectranetics 13f tightrail sub-c rotating dilator sheath was used next, but after some advancement, concerns about potential damage to adjacent leads prompted a switch back to the glidelight, but no progress could be made.The extensive lead on lead binding required working over an hour on the rv lead (with significant traction forces being applied) to attempt advancement within the vasculature.A spectranetics visisheath dilator sheath was used over the glidelight to attempt to separate the lead on lead binding, which resulted in minimal advancement.At that time the active lv lead had been pulled back due to the lead on lead binding while attempting extraction of the rv lead.An lld was inserted into the active lv lead and it was successfully removed.The physician focused attempt to remove the abandoned lv lead, thinking this would create additional space to extract the rv lead.A spectranetics 11f tightrail with its outer sheath was used, and made significant progress, nearly reaching the superior vena cava (svc).However, the abandoned lv snapped; the lld was removed in its entirety, along with the lv lead remnant and the tightrail.The tightrail's outer sheath was left in place to maintain access for re-implantation of the new rv lead.A stiff wire was introduced, reaching the rv with no hemodynamic changes noted, and the outer sheath was removed with no significant changes in blood pressure.A long 7f sheath was inserted over the stiff wire into the rv, when the patient's blood pressure dropped.Rescue efforts began immediately, including rescue balloon and sternotomy.Wide perforations of the innominate and svc were discovered, and the ra lead was removed from the patient.Unfortunately, the repairs were unsuccessful and the patient did not survive.The physician believed traction forces caused the perforations.This report captures the lld providing significant traction to the rv lead when the perforations occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: SPECTRANETICS 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: 16736065
• MDR Text Key: 313260104
• Report Number: 1721279-2023-00057
• 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: 04/13/2023

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: 04/13/2023
• 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 1458Q LV LEAD.; ABBOTT 1699TC RA PACING LEAD.; ABBOTT 7001 RV ICD LEAD.; ABBOTT LV LEAD MODEL UNK.; LONG 7F SHEATH MANUFACTURER UNK.; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICES IN LV LEADS.; SPECTRANETICS VISISHEATH DILATOR SHEATH.; STIFF WIRE MANUFACTURER/SIZE UNK.
• Patient Outcome(s): Death; Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic