MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRACOR BREAST TISSUE MARKER

Catalog Number SMUC10C

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records have been made available to the manufacturer.Medical images were provided and are being evaluated.The device remains implanted and has not been returned to the manufacturer for evaluation.As the lot number for the device was provided, a review of the device history records is currently being performed.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 post breast biopsy mri, the marker clip allegedly had a blooming artifact of one cm.It was further reported that the lesion was greater than one cm, therefore the artifact did not obscure the image of the lesion.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 image provided, a blooming artifact was identified in the mri breast image, can be confirmed.Based on the image provided, it is unknown if a blooming artifact was located in the right or left breast.Conclusion: the device wireform remains implanted within the patient and was not returned for evaluation.However, based on the review of the returned image, the investigation is confirmed for the reported blooming artifact.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 marker.Therefore, optimization of mr imaging parameters to compensate for the presence of this device may be necessary." 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 post breast biopsy mri, the marker clip allegedly had a blooming artifact of one cm.It was further reported that the lesion was greater than one cm, therefore the artifact did not obscure the image of the lesion.There was no reported patient injury.

• Brand Name: SENOMARK ULTRACOR 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): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5756860
• MDR Text Key: 49033611
• Report Number: 2020394-2016-00584
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123911
• 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: 06/02/2016

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Catalogue Number: SMUC10C
• Device Lot Number: VT16A0061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial