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

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.

• Brand Name: ULTRACLIP DT BREAST TISSUE MARKER
• Type of Device: BREAST 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 Key: 5767518
• MDR Text Key: 48713889
• Report Number: 2020394-2016-00609
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 864017DL
• Device Lot Number: HUAP0242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1