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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH
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THE SPECTRANETICS CORPORATION SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH Back to Search Results
Model Number 545-511
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Perforation of Vessels (2135); Iatrogenic Source (2498)
Date of Event 03/07/2018
Type of Reportable Event Serious Injury
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Brand Name
SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH
Common Device Name
TIGHTRAIL
Manufacturer (Section D)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
MDR Report Key7430930
Report Number1721279-2018-00044
Device Sequence Number1216889
Product Code DRE
UDI-Device IdentifierM204545511AA0
UDI-PublicM204545511AA0
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K150360
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/26/2018
Report Date (Section F) 01/01/2005
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Physician
Device Model Number545-511
Device Catalogue Number545-511
Device Lot NumberUNAVAILABLE
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number0
Concomitant Medical Products
and Therapy/Usage Dates
SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS LLD EZ LEAD LOCKING DEVICE; SPECTRANETICS VISISHEATH DILATOR SHEATH
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age37 YR
Date Report Sent to FDA01/01/2005
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