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

Model Number	SMEC10GSS
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	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.The device has 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 or Problem Description
It was reported that post breast tissue marker placement, the marker applicator tip was noted to have detached.There was no reported patient injury.
Event or Problem Description
It was reported that post breast tissue marker placement under stereotactic guidance, the marker applicator deployed part of the marker after removal from the probe.There was no reported patient injury.
Additional Manufacturer Narrative
After further review of the additional information received and the evaluation details, the information indicates a failure to separate.It was reported that post breast tissue marker placement under stereotactic guidance, two marker applicators deployed part of the marker after removal from the probe, which resulted in the device failing to separate, not detachment of the device.There was no reported patient injury.After receipt of this information, this event was reassessed and determined to be not mdr reportable.However, an initial mdr has already been submitted; therefore, the purpose of this supplemental report is to document the change in reportability classification.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: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7287759
• Report Number: 2020394-2018-00141
• Device Sequence Number: 16512956
• Product Code: NEU
• UDI-Device Identifier: 00801741031915
• UDI-Public: (01)00801741031915
• Combination Product (Y/N): N
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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: 02/01/2019
• Device Model Number: SMEC10GSS
• Device Catalogue Number: SMEC10GSS
• Device Lot Number: VTBX00441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1