SPECTRANETICS LEAD LOCKING DEVICE 518-062

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-05 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.

Event Text Entries

[177838928] Patient's date of birth unavailable. Patient's weight unavailable. Device lot number, expiration date unavailable. Device manufacture date unavailable because lot number is unavailable.
Patient Sequence No: 1, Text Type: N, H10


[177838929] A complex lead extraction procedure commenced to remove three leads: two right ventricular (rv) leads and one right atrial (ra) lead due to non function and one redundant rv lead. The patient had three separate and distinct venous entry sites in the subclavian vein, one for each lead which had been implanted. Several different devices were in use to aid in the extractions of the three very heavily fibrosed leads, and several devices entered and exited the subclavian entry sites during extraction. During the procedure, the patient did not exhibit any hemodynamic changes, such as a drop in blood pressure. However, after the leads had been extracted, it was noted that there was persistent bleeding from the pocket. Per report, the cardiac surgeon was in the procedure room at least the last 30 minutes of the extraction procedure. Ultimately, a rescue device was used to provide hemostasis to the subclavian area while the decision was made to perform a sternotomy. Once in the chest, the surgeon confirmed that there was no additional injury to the subclavian region other than dilatation of the entry sites due to the extraction tools used, which is part of the clinical lead extraction procedure. However, the physician discovered injuries in the right atrial wall and in the right ventricle. It was reported that the patient's tissues were very thin but repairs were successful. However, when patient was taken off pump after surgery, her heart stopped and she expired. It was noted that the patient had a previous sternotomy performed (reason unknown). However, the likely reason that the patient did not exhibit hemodynamic compromise is that the pericardium was stuck to the myocardium from adhesions, preventing any pericardial effusion, per thoughts from philips senior medical advisor/cardiologist. There was no delay in obtaining blood or performing the sternotomy; the lead extraction procedure was performed in the operating room. This report captures the ra wall injury in which a spectranetics lead locking device (lld) was used inside the ra lead as the lead's traction platform (please refer to mdr 1721279-2020-00021 which captures the rv perforation). Attempts continue to obtain further information regarding the patient's medical condition prior to the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721279-2020-00022
MDR Report Key9672508
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-05
Date of Report2020-01-08
Date of Event2020-01-08
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-01-08
Date Added to Maude2020-02-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. BARBARA CREEL
Manufacturer Street9965 FEDERAL DRIVE
Manufacturer CityCOLORADO SPRINGS CO 80921
Manufacturer CountryUS
Manufacturer Postal80921
Manufacturer Phone719447-246
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameSPECTRANETICS LEAD LOCKING DEVICE
Generic NameLLD
Product CodeDRB
Date Received2020-02-05
Model Number518-062
Catalog Number518-062
Lot NumberUNAVAILABLE FROM FACILITY
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerTHE SPECTRANETICS CORPORATION
Manufacturer Address9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921

Device Sequence Number: 101

Product Code---
Date Received2020-02-05
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-02-05

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