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

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.

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 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
• Type of Device: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7950012
• MDR Text Key: 123840942
• Report Number: 2020394-2018-01885
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032301
• UDI-Public: (01)00801741032301
• Combination Product (y/n): N
• PMA/PMN Number: K063238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• 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 Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 864017
• Device Catalogue Number: UNKUCLIPII
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization