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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWIRL MARKER BREAST TISSUE MARKER

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BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWIRL MARKER BREAST TISSUE MARKER Back to Search Results
Model Number UCTW17
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Reaction (2414)
Event Date 06/05/2019
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. (expiry date: 11/2021).
 
Event Description
It was reported that during an ultrasound-guided breast tissue marker placement procedure into hard tissue, the device allegedly was found to be potentially incompatible with the patient. It was further reported that upon test results two weeks post procedure, it was discovered the patient was allegedly allergic to a component of the device. A coaxial was used during the procedure and the procedure was completed by using the same marker. The patient was reportedly stable and will have the marker surgically removed.
 
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Brand NameULTRACOR TWIRL MARKER
Type of DeviceBREAST TISSUE MARKER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
INFUS MEDICAL (THAILAND)
706 moo 4
bangpoo ind estate
samutprakarn province 10280
TH 10280
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9545998
MDR Text Key175112833
Report Number2020394-2019-05898
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUCTW17
Device Catalogue NumberUCTW17
Device Lot NumberHUCY2257
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 Received12/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2019
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: 01/03/2020 Patient Sequence Number: 1
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