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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 UNK ULTRACLIP DT
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown. Visual inspection: the device was not returned; therefore, a visual inspection could not be performed. Functional/performance evaluation: the device 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: images/photos were not provided; therefore, a review could not be performed. Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation. 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 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 post breast tissue marker placement, under mri imaging, the artifact from the breast marker was larger than normal. It was further reported that the artifact obscured the biopsied area, which inhibited the health care professionals ability to see the extent of disease. There is no known impact or consequence to the patient.
 
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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 Key5964588
MDR Text Key55203483
Report Number2020394-2016-00890
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 09/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK ULTRACLIP DT
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 Received09/07/2016
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: 09/20/2016 Patient Sequence Number: 1
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