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

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 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: 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.

• 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: 5764065
• MDR Text Key: 48614916
• Report Number: 2020394-2016-00600
• 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: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ULTRACLIP DT
• Device Lot Number: UNKNOWN
• 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
• 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
• Patient Outcome(s): Other