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

Model Number	864017
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
H10: 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 citation: 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.H10: g4 (pma/510k).H11: b5 (event), b7 (other relevant history), d4 (lot#), e1 (initial reporter name and address).H11:section a through f - 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 or Problem Description
It was reported in an article from 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 which obscures assessment of the surrounding tissue when imaging.

• Brand Name: ULTRACLIP II BREAST TISSUE MARKER
• Common Device Name: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7950012
• Report Number: 2020394-2018-01885
• Device Sequence Number: 1343698
• Product Code: NEU
• UDI-Device Identifier: 00801741032301
• UDI-Public: (01)00801741032301
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 864017
• Device Catalogue Number: UNKUCLIPII
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization