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 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.

• 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: 5778730
• MDR Text Key: 49061069
• Report Number: 2020394-2016-00622
• 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,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 864017DL
• Device Lot Number: HUZK0530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2015
• 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