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

Catalog Number	SMEC10R
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a breast biopsy procedure with the encor probe and marker placement with a senormark ultra.During the procedure, a click sound was heard during vacuuming and the patient felt pain.The device was not fully closed, and an obstruction was felt.The marker was successfully deployed.However, the proved was not fully closed after removal.It was further reported that the patient was experiencing significant bleeding, and a large hematoma was present.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged difficult to insert 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 d4 (unique identifier (udi) #), g3, h6 (method, result, conclusion).Section a through f ¿ the information provide 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a breast biopsy procedure with the encor probe and marker placement with a senormark ultra.During the procedure, a click sound was heard during vacuuming and the patient felt pain.The device was not fully closed, and an obstruction was felt.The marker was successfully deployed.However, the proved was not fully closed after removal.It was further reported that the patient was experiencing significant bleeding, and a large hematoma was present.The current status of the patient is unknown.

• Brand Name: SENOMARK ULTRA BREAST TISSUE MARKER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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: 22931668
• Report Number: 2020394-2025-01372
• Device Sequence Number: 10223445
• Product Code: NEU
• UDI-Device Identifier: 00801741032035
• UDI-Public: (01)00801741032035(11)240902(17)270801(10)VTJV00436
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K123911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SMEC10R
• Device Lot Number: VTJV00436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 65 KG