MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GHIATAS; BREAST LOCALIZATION WIRE

Catalog Number 470201

Device Problem Break (1069)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  Injury  

Event Description

It was reported that during a biopsy procedure through scattered density tissue, the barb of the device allegedly had a break.Reportedly, the broken pieces were retrieved from the patient.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 04/2026) 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.H3 other text : device pending return.

Manufacturer Narrative

H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.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.Three images were provided and reviewed.First and second image shows that the 3 wires are within the left breast, one is an intact wire traversing a biopsy proven malignant mass that has an adjacent tissue marker (will refer to this as wire #1).This is in customary position.Just anterior to this, there is a wire that does not contain the hook at the distal tip.This wire has been significantly retracted (will refer to this as wire #2).Additionally, there is a third wire which has been placed posterior to the first two wires (will refer to this as wire #3).The tip of this wire is adjacent to a small linear piece of metal which is allegedly the tip of the previously described wire.This would indicate that the hook portion of wire #2 fractured during placement.The allegedly fractured hook portion is located slightly (approximately 2cm) medial to the targeted mass.Third image show that the two intact wires, the tissue marker, multiple surgical clips, and the small linear piece of metal which is allegedly the tip of the previously described wire #2.On discussion, wire localization is performed prior to surgery in order to help the surgeon locate the area to be excised in the operating room.The wire is placed by the radiologist, with the tip of the wire at the site to be excised and the proximal portion of the wire remaining outside the breast so that the surgeon can follow the wire from the skin to the excision location.But it appears that the wire fractured at some point during placement, leaving the hooked tip of the wire in the breast.It is also noted that the hook portion of the wire is what latches into the tissue so that the needle stays in place in the breast and does not migrate away from the lesion that is to be excised.Ghiatas wires are made to be flexible, and fracture of the wire is extremely rare but may occurred due to a defective wire.There is a possibility that wire has been bent sharply which have caused fracture.It is also noted that a third wire was placed in order to localize and subsequently remove the fractured fragment.It also would have been fine to leave the small wire tip in the breast, as it would not cause any detrimental effects to the patient.It's also possible that the tip would have been incidentally included in the lumpectomy specimen and removed anyway.Therefore based on the image review, the investigation is confirmed for the reported break as it was noted that the wire has been fractured.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.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.H3 other text : device not returned.

Event Description

It was reported that during a biopsy procedure through scattered density tissue, the barb of the device was allegedly broken off in the patient twice.Reportedly, surgery was done to retrieve the broken pieces as well as the defective device was removed from the patient.The patient is reported to be stable now.

• Brand Name: GHIATAS
• Type of Device: BREAST LOCALIZATION WIRE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18316541
• MDR Text Key: 330328089
• Report Number: 2020394-2023-01244
• Device Sequence Number: 1
• Product Code: GDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 470201
• Device Lot Number: REHS1836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female