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

Catalog Number	SMEC10R
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 09/2024).H11: section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that during a biopsy breast tissue marker placement procedure, the clip was allegedly not displayed on the control mammogram and jam occurred between the needle opening and the clip device thus the needle was tried to be removed manually.It was further reported that the patient allegedly felt pain and discomfort since resistance was developed when trying to remove the needle.Reportedly, a new image was taken where the clip was not visible, which allegedly remained at the tip of the the needle.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a stereotactic guided breast tissue marker placement procedure through normal density tissue, the clip was allegedly not displayed on the control mammogram and jam occurred between the needle opening and the clip device thus the needle was tried to be removed manually.It was further reported that the patient allegedly felt pain and discomfort since resistance was developed when trying to remove the needle.Reportedly, a new image was taken where the clip was not visible, which allegedly remained at the tip of the the needle.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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: the physical device was not returned for evaluation.Two electronic photos were provided and reviewed.In the both photos, it seems like tip of the marker and tissue like material were presented in the needle.Based on the photo review, the both reported difficult to remove and separation failure cannot be confirmed as there is no proper evidence to confirm the reported event.Therefore, the investigation is inconclusive for the both reported difficult to remove and separation failure as there is no proper evidence provided in the provided photos.A definitive root cause for both the reported separation failure and difficult to remove issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiration date: 09/2024), g3, h6 (method).H11: section a through f ¿ the information provided by bd represents all 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 bd.

• Brand Name: SENOMARK ULTRA BREAST TISSUE MARKER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18054293
• Report Number: 2020394-2023-00972
• Device Sequence Number: 12503185
• Product Code: NEU
• UDI-Device Identifier: 00801741032035
• UDI-Public: (01)00801741032035
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K123911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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 Catalogue Number: SMEC10R
• Device Lot Number: VTFW00584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 65 KG