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

Model Number	SMMA11R
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during placement of a breast tissue marker, the marker applicator allegedly was difficult to remove from the probe.There was no reported patient injury.
Event or Problem Description
It was reported that during placement of a breast tissue marker, the marker applicator allegedly was difficult to remove from the probe.There was no reported patient injury.
Additional Manufacturer Narrative
A lot history review was conducted and it was determined that a device history record (dhr) review was not required, however requested.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.One senomarkultra marker applicator was returned for evaluation.The marker applicator was received with the distal tip detached and not returned.No pga pads or wireform were returned with the marker applicator.The plunger rod was removed from the marker applicator without issue and slight damage noted.Functional testing was not viable due to the returned sample condition.Therefore, based on the returned sample condition, the investigation is confirmed for the identified detached distal tip and inconclusive for the reported removal difficulties.Removal difficulties likely led to the detached marker applicator tip.However, the definitive root cause for the removal difficulties and detached tip could not be determined based upon the available information.It is unknown if procedural issues contributed to the reported event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: SENOMARK ULTRA 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: 7949058
• Report Number: 2020394-2018-01883
• Device Sequence Number: 11178814
• Product Code: NEU
• UDI-Device Identifier: 00801741032073
• UDI-Public: (01)00801741032073
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123911
• 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,Followup
• Report Date (Section B): 12/19/2018

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 Model Number: SMMA11R
• Device Catalogue Number: SMMA11R
• Device Lot Number: VTAV00446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1