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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 05/31/2016
Event Type  malfunction  
Manufacturer Narrative
No hospital/medical records have been made available to the manufacturer, however medical images have been provided and are currently being reviewed. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. 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 that during a pre-operative mri scan, the artifact from the breast tissue marker was allegedly larger than expected. It was further reported that the breast tissue marker remains implanted. There was no reported patient injury.
 
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 as 14. 2mm by the facility, can be confirmed. Based on the images provided, two mri breast images demonstrated another biopsy marker that identified a mass; the mass was digitally measured as 13. 2mm by the facility, less than a 2mm artifact from the biopsy marker which did not obscure the mass, can be confirmed. Conclusion: although the sample was not returned for evaluation, x-ray 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, "mri image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the 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. 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 that during a pre-operative mri scan, the artifact from the breast tissue marker was allegedly larger than expected. It was further reported that the breast tissue marker remains implanted. There was no reported 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 Key5778730
MDR Text Key49061069
Report Number2020394-2016-00622
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,Followup
Report Date 06/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Catalogue Number864017DL
Device Lot NumberHUZK0530
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 Received08/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2015
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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