MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. UltraCor Twirl Marker; Breast Tissue Marker

Catalog Number	UCVR17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a breast tissue marker placement procedure using the ultracor twirl clover marker.During the procedure, the twirl clover marker split into two pieces when an attempt was made to remove it during a vab procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was 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 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) 2026, a patient underwent a breast tissue marker placement procedure using the ultracor twirl clover marker.During the procedure, the twirl clover marker split into two pieces.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.Four x ray images were provided and reviewed.The x rays were two different mammograms.The provided mammograms demonstrate a clover shaped ultracor twirl post biopsy breast tissue marker in the upper outer left breast.In the first mammogram, the marker maintains its intact clover shape.In the second mammogram, the marker appears fragmented, with the pieces separated from one another, and a new coil shaped marker is visible nearby.The presence of air from the vacuum assisted biopsy device suggests that the second mammogram was obtained immediately following the procedure.Based on the image review, the reported event break can be confirmed.Therefore, the investigation is confirmed for the reported break as the marker broken into pieces were noted in the provided images.A definitive root cause for the alleged 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.B5, 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25158270
• Report Number: 2020394-2026-01185
• Device Sequence Number: 9325292
• Product Code: NEU
• UDI-Device Identifier: 00801741226342
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: UK
• PMA/510(K) Number: Unknown
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: UCVR17
• Device Lot Number: HUKW1480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• 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