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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD
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THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD Back to Search Results
Model Number 518-039
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation of Vessels (2135); Iatrogenic Source (2498)
Event Date 04/27/2018
Event Type  Injury  
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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 Key7526461
Report Number1721279-2018-00062
Device Sequence Number1
Product Code DRB
Reporter Country CodeUS
PMA/PMN Number
K990713
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 01/01/2005,04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Expiration Date10/16/2019
Device Model Number518-039
Device Catalogue Number518-039
Device Lot NumberFLJ17K12A
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 Received04/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2017
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 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS VISISHEATH DILATOR SHEATH
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age51 YR
Patient Weight88
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