Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD Back to Search Results
Model Number 518-067
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation of Vessels (2135); Iatrogenic Source (2498)
Event Date 06/04/2018
Event Type  Injury  
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPECTRANETICS LEAD LOCKING DEVICE
Type of Device
LLD
Manufacturer (Section D)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
Manufacturer Contact
barbara creel
9965 federal drive
colorado springs, CO 80921
719447-246
MDR Report Key7655752
Report Number1721279-2018-00080
Device Sequence Number1
Product Code DRB
UDI-Device Identifier00813132023072
UDI-Public00813132023072
Reporter Country CodeJA
PMA/PMN Number
K142116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/01/2005,06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Expiration Date11/28/2019
Device Model Number518-067
Device Catalogue Number518-067
Device Lot NumberFLP17L13A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number0
Treatment
SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS GLIDELIGHT 500-301 LASER SHEATH; SPECTRANETICS GLIDELIGHT 500-302 LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
Patient Weight80
-
-