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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUGUIDE COAXIAL BIOPSY INSTRUMENT

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BARD PERIPHERAL VASCULAR, INC. TRUGUIDE COAXIAL BIOPSY INSTRUMENT Back to Search Results
Model Number C1820B
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 04/28/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/ evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/ patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. (expiration date: 03/2022).
 
Event Description
It was reported that during an ultrasound guided biopsy, the coaxial allegedly broke inside the patient. The device was removed in an additional surgery operation. The patient is reportedly stable.
 
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Brand NameTRUGUIDE COAXIAL
Type of DeviceBIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX 88780
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10082873
MDR Text Key191829532
Report Number2020394-2020-03497
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K936194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC1820B
Device Catalogue NumberC1820B
Device Lot NumberREDR3034
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/22/2020 Patient Sequence Number: 1
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