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

Model Number	SMTEC10G
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one partial senomark marker applicator was returned for evaluation.The marker applicator was returned with the distal end of the applicator detached.One pushpad was returned within the marker applicator and the wireform was not returned.Therefore, the investigation is confirmed for the identified detachment and inconclusive for the reported failure to separate issue.The definitive root cause for the reported failure to separate and identified tip detachment could not be determined based upon the available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current senomark breast tissue marker instructions for use (ifu) state: general information and device description: -the marker contains resorbable polyglycolic acid (pga) pads, one polyethylene glycol (peg) push pad, and one titanium or stainless steel wireform.The pads are visible via ultrasound for approximately 3 weeks and are essentially resorbed in approximately 12 weeks.The syringe-like applicator fits within the encor probe to access the biopsy cavity.The pads are deployed from the applicator through the biopsy device into the biopsy cavity.Contraindications: -there are no known contraindications.Warnings: -this device has been designed for single use only.Reuse of this device bears the risk of cross-patient contamination, as medical devices with long and small lumina, joints, and/or crevices between components are difficult or impossible to clean.-do not resterilize.-avoid the use of excessive force during removal of the applicator to prevent breakage of the applicator tip.Precautions: -the device should only be used by physicians trained in percutaneous biopsy procedures.-maintain correct alignment of the yellow indicator key with the red arrow of the biopsy probe when dispending pads.Ensure that all pads are dispensed.Potential complications: potential complications that may be associated with the use of senomark biopsy site marker are similar to those associated with the use of other biopsy marking devices.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 or Problem Description
It was reported that during breast marker placement under stereotactic guidance, the marker allegedly remained in the marker applicator.There was no reported patient injury.

• Brand Name: SENOMARK BREAST TISSUE MARKER
• Common Device Name: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7300773
• Report Number: 2020394-2018-00164
• Device Sequence Number: 957412
• Product Code: NEU
• UDI-Device Identifier: 00801741031977
• UDI-Public: (01)00801741031977
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K050090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: SMTEC10G
• Device Catalogue Number: SMTEC10G
• Device Lot Number: VTAY00606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1