MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWIRL MARKER; BREAST TISSUE MARKER

Catalog Number	UCTW17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
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 device has not been returned to the manufacturer for evaluation.However, images 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) 2026, a patient underwent a breast marker procedure by using ultracor twirl breast tissue marker.It was reported that post procedure mammographic imaging showed that the marker was allegedly fragmented.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2026, a patient underwent a breast marker procedure by using ultracor twirl breast tissue marker.It was reported that post procedure mammographic imaging showed that the marker was allegedly fragmented.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One ct image was provided and reviewed.This image demonstrates a mass within the right breast.The mass contains a post biopsy breast tissue marker.As reported in the complaint, the marker does not demonstrate the expected shape (of a ring or curls).Though the marker is broken, it is in its expected location within the mass, and the pieces are immediately adjacent to one another.Though rare, the ring structure can break, resulting in the marker no longer having its expected shaped appearance (ring or curls).If the biopsy results are malignant, the marker is still visible by both mammogram and ultrasound and can be targeted for wire localization if necessary.If the biopsy results are benign and the mass is not surgically removed, the marker can remain in the patient indefinitely, regardless of its shape.Based on the image review, the reported event can be confirmed.Therefore, the investigation is confirmed for the reported break as marker was noted to be broken based on the image review.A definitive root cause for the reported break 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.G2, 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.

• Brand Name: ULTRACOR TWIRL MARKER
• Common Device Name: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24301763
• Report Number: 2020394-2026-00207
• Device Sequence Number: 9471522
• Product Code: NEU
• UDI-Device Identifier: 00801741109416
• UDI-Public: (01)00801741109416(17)270928(10)HUJX0720
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K180061
• 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): 04/20/2026

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: UCTW17
• Device Lot Number: HUJX0720
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown