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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DT BREAST TISSUE MARKER Back to Search Results
Catalog Number 864017DL
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/09/2016
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event. Visual inspection: the sample was not returned; therefore, a visual inspection could not be performed. Functional/performance evaluation: the sample was not returned; therefore, a functional/performance evaluation could not be performed. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: based on the images provided, a mri breast image demonstrated an artifact was digitally measured at 13mm within a large mass, can be confirmed. Conclusion: although the sample was not returned for evaluation, two images were provided for review. Based on the image review, the investigation is confirmed for the reported issue, as an artifact was identified in the mri images provided. Per the reported event details, the biopsy clip was visualized under mri imaging. The current ifu states, "mr image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the ultraclip dual trigger breast tissue marker. Therefore, it may be necessary to optimize mr imaging parameters for the presence of this metallic implant. " it is possible that procedural issues and/or imaging techniques contributed to the reported event. However, based upon the available information, the definitive root cause is unknown. Labeling review: the current instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.
 
Event Description
It was reported that during a pre-operative mri scan, the artifact from the breast marker was allegedly larger than expected (13mm in diameter). It was further reported that the carcinoma was larger than the artifact; therefore, the artifact did not cause any patient complications. Reportedly the marker remains implanted and there was no patient injury.
 
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Brand NameULTRACLIP DT 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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5767518
MDR Text Key48713889
Report Number2020394-2016-00609
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number864017DL
Device Lot NumberHUAP0242
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 Received06/09/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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