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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN THORACIC NAVIGATION SYSTEM
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VERAN MEDICAL TECHNOLOGIES, INC SPIN THORACIC NAVIGATION SYSTEM Back to Search Results
Model Number SYS-4000
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Blood Loss (2597)
Date of Event 02/27/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Veran is submitting this mdr as part of an overall retrospective review in response to an fda form 483 that was issued to the firm as of january 2019.
 
Event or Problem Description
System performed as intended; no malfunction.Doctor began with ebus before switching over to navigation.Was able to collect a few biopsies using the forceps before having to abort the procedure as a result of excessive bleeding.Insufficient information to determine treatment for bleeding.
 
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Brand Name
SPIN THORACIC NAVIGATION SYSTEM
Common Device Name
SPIN THORACIC NAVIGATION SYSTEM
Manufacturer (Section D)
VERAN MEDICAL TECHNOLOGIES, INC
1908 innerbelt business center
saint louis MO 63114
MDR Report Key9401561
Report Number3007222345-2019-00012
Device Sequence Number11368581
Product Code JAK
UDI-Device Identifier00815686020101
UDI-Public00815686020101
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K170023
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberSYS-4000
Device Catalogue NumberSYS-4000
Device Lot Number82601170511
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/27/2018
Initial Report FDA Received Date12/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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