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

Model Number	SMEC10R
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that during placement of a breast tissue marker, a tubular, paper-like material allegedly was found upon removal of the marker applicator from the patient.It was further reported that the marker was not deployed.There was no reported patient injury.
Event or Problem Description
It was reported that during placement of a breast tissue marker, a tubular, paper-like material allegedly was found upon removal of the marker applicator from the patient.It was further reported that the marker was not deployed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complaint history review (chr) was conducted and it was determined that a device history record (dhr) review was required.The dhr has 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: five senomark ultra markers were returned, one original sample and four sealed lot samples.A visual and functional evaluation was performed.The devices appeared to be clean.The tip guide and tip protector was returned for each marker applicator.The original sample was inspected and the applicator was received with the plunger partially depressed.However, the 3 pga pads and wireform were present within the applicator.The first pga pad was visible at the aperture of the applicator.No other anomalies were noted and no foreign material was returned or noted with the device.Additionally, the four lot samples were inspected without issue.Functional testing of the original sample noted no anomalies as the 3 pga pads were deployed without issue.Inspection of the pads noted that in comparing the 1st and 3rd pga pads, the 1st pad was slightly smaller in size than the 3rd pad.The pva and wireform were in placed within the 2nd pad.Functional testing was not performed on the lot samples as no anomalies were noted and due to the nature of the reported event.Based on the available information, the investigation will remain inconclusive for foreign material present in device as the original device was returned open and the alleged paper-like material was not returned for evaluation.While, a definitive root cause could not be determined based upon available information, it is possible that the alleged tubular piece of white paper-like material was a piece of pga pad.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.Expiry date: 02/2021.H11:section a through f - 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.

• Brand Name: SENOMARK BREAST TISSUE MARKER
• Common Device Name: IMPLANTABLE CLIP
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7970882
• Report Number: 2020394-2018-01913
• Device Sequence Number: 1255511
• Product Code: NEU
• UDI-Device Identifier: 00801741032035
• UDI-Public: (01)00801741032035
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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 Model Number: SMEC10R
• Device Catalogue Number: SMEC10R
• Device Lot Number: VTCP00051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1