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 2020-02-12 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.

Event Text Entries

[178777339] A lead extraction procedure commenced to remove two right ventricle (rv) leads, one of which was capped, a right atrium (ra) lead, and a left ventricle lead (lv) due to occlusion. When the physician was using the spectranetics 14f glidelight laser sheath on the capped rv lead to extract it, the patient's blood pressure dropped. Rescue interventions then commenced. A sternotomy was performed and a superior vena cava/right atrium (svc/ra) tear was discovered and attempted to be repaired. Rescue interventions were not successful and the patient expired. No leads were removed during the procedure. The physician believes that while lasing on the lead, the glidelight device jumped forward, causing the injury. However there was no alleged malfunction of the glidelight device, nor any other spectranetics devices used during the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721279-2020-00031
MDR Report Key9700113
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-12
Date of Report2020-01-15
Date of Event2020-01-15
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-01-15
Date Added to Maude2020-02-12
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 Received2020-02-12
Model Number518-062
Catalog Number518-062
Lot NumberFLP19G08A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 Received2020-02-12
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-02-12

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