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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACLIP II BREAST TISSUE MARKER

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BARD PERIPHERAL VASCULAR, INC. ULTRACLIP II BREAST TISSUE MARKER Back to Search Results
Model Number 864017
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not 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. Journal article review: the journal article ¿breast tissue markers: why? what¿s out there? how do i choose? was based on the purpose and use of breast tissue markers placement, unique features of biopsy markers and modality specific disability. The article also discussed patient consent biopsy tissue marker migration and what factors one should consider when selecting a specific biopsy marker based on modality used. The article reported that some biopsy clips made of stainless steel and biodur 108 are susceptible to causing mri artifact. Three mri images that demonstrated artifact were identified as biodur 108 breast tissue marker. There is no specific patient details or information surrounding artifact identified in mri images. Shah, d. , mehta, a. , talati, n. , brem, r. , margolies, l. (2018). Breast tissue markers: why? what¿s out there? how do i choose?. Clinical imaging, 52, 123-136. Https://doi. Org/10. 1016/j. Clinimag. 2018. 07. 003. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported in an article in clinical imaging titled 'breast tissue markers: why? what's out there? how do i choose?' that some breast tissue markers made of stainless steel and biodur 108 are susceptible to creating mri artifacts.
 
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Brand NameULTRACLIP II BREAST TISSUE MARKER
Type of DeviceBREAST TISSUE MARKER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD SHANNON LIMITED
san geronimo industrial park
lot #1, road #3, km 79.7
humacao 00791
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key7950012
MDR Text Key123840942
Report Number2020394-2018-01885
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number864017
Device Catalogue NumberUNKUCLIPII
Device Lot NumberUNKNOWN
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 Received10/29/2019
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: 10/09/2018 Patient Sequence Number: 1
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