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

Catalog Number	UCTW17
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
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, photos 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) 2025, a patient underwent a breast tissue marker placement procedure through normal density tissue using the ultracor twirl breast tissue marker.During the procedure, the clip didn¿t detach from the insertion device after deployment.It remained attached at the tip and pulled through breast tissue during removal, causing significant pain.The clip ended up approximately 2 cm from the biopsy site.It was further reported that pressure required to depress the plunger.The patient experienced pain and distress due to the dragging.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a breast tissue marker placement procedure through normal density tissue using the ultracor twirl breast tissue marker.During the procedure, the clip did not detach from the insertion device after deployment.It remained attached at the tip and pulled through breast tissue during removal, causing significant pain.The clip ended up approximately 2 cm from the biopsy site.It was further reported that pressure required to depress the plunger.The patient experienced pain and distress due to the dragging.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.Five number of medical image(s) were reviewed.There are 3 ultrasound images and 2 post-biopsy mammogram images.The ultrasound images show a hyperechoic object within the breast which is labeled "clip", presumably the ultracor twirl marker.The mammogram images show an ultracor twirl tissue marker within the breast, though the image is cropped so its exact location is unclear.The last stage of an ultrasound guided breast biopsy is the placement of a breast tissue marker.Tissue markers need to be completely dislodged from the needle prior to removal.There is always a risk that the marker will not completely dislodge from the needle; if this happens the marker will be removed along with the needle.For this reason, always twist the entire deployment device 360-720 degrees after pushing the button to deploy the marker.This helps ensure that the marker has completely dislodged.There is no way to know if the radiologist in this case properly inserted the tissue marker.It is possible that the marker adhered to the needle and would not properly deploy.Either way, in the case that the marker does not deploy properly, the radiologist can simply place a different marker.The original marker does not need to be removed.Based on the image review, the reported events could not be confirmed based on the provided review.Three electronic photos were provided and reviewed.The first photo shows a ultracor twirl breast biopsy marker needle part, as the plunger was noted to be fully depressed.The second photo was the zoom view of same ultracor twirl breast biopsy marker needle part.Marker was not found on both the photos.The third photo shows the product labelling information of the ultracor twirl breast biopsy marker, which matches / verified with the tw details.No other anomalies were observed.Based on the photo review, the reported events cannot be confirmed.Therefore, the investigation is inconclusive for the reported positioning failure, separation failure and difficult to remove issues as no objective evidence was provided for review.A definitive root cause for the alleged positioning failure, separation failure and difficult to remove issues 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.

• 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: 23152111
• Report Number: 2020394-2025-01582
• Device Sequence Number: 5218269
• Product Code: NEU
• UDI-Device Identifier: 00801741109416
• UDI-Public: (01)00801741109416(11)240830(17)270628(10)HUJU1492
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: HUJU1492
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2024
• 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
• Patient Sex: Unknown