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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. GHIATAS; BREAST LOCALIZATION WIRE Back to Search Results
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  
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.
 
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.
 
Event Description
It was reported that during a biopsy procedure through scattered density tissue, the device was allegedly broken inside the patient.It was further reported that the device fragments were removed by surgery.The status of the patient is reported to be stable.
 
Manufacturer Narrative
H10: 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.Three electronic images were reviewed.Two images show three wires within the left breast from different views.The third image was of a specimen.Wire #1 is an intact wire traversing a malignant mass.A biopsy marker is identified adjacent to the wire.The event for wire #1 is captured in this complaint and reported via this 3500a report.Wire #2 is anterior to the first wire.Wire #2 was noted to be significantly retracted and does not have a hook at the tip.The event for wire number #2 is covered under another complaint record and reported via 3500a mfr report # 2020394-2023-01244.Wire #3 is placed posterior to the first two wires.The tip of this wire is adjacent to the tip of the second wire which was fractured.The fractured hook from wire #2 is located medial to the target mass.As there was no alleged deficiency with wire number #3, no complaint record was opened for this event.The specimen photograph shows the following: two intact wires, a tissue marker, multiple surgical clips, and the small linear piece of metal (tip of wire #2).Based on the image review, the investigation for the reported break of wire #1 is unconfirmed, as only one wire out of the three implanted wires was noted to be broken.The broken wire #2 is captured under mfr report # 2020394-2023-01244.A definitive root cause for the alleged break could not be determined based upon the provided information.It is unknown whether patient and/or procedural issues contributed to the reported event.H10: d4 (expiry date: 04/2026), g3, h6 (method) h11: b5, h1, h6 (patient, result, conclusion) 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 : see h10.
 
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Brand Name
GHIATAS
Type of Device
BREAST LOCALIZATION WIRE
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 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 Key18308556
MDR Text Key330328607
Report Number2020394-2023-01241
Device Sequence Number1
Product Code GDF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
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 02/09/2024
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
Device Operator Health Professional
Device Catalogue Number470201
Device Lot NumberREHS1836
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/20/2023
Initial Date FDA Received12/12/2023
Supplement Dates Manufacturer Received02/09/2024
Supplement Dates FDA Received02/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient SexFemale
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