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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWIRL MARKER BREAST TISSUE MARKER Back to Search Results
Model Number UCTW17
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown. Investigation summary: the sample was not returned. No photos or images were provided for review. Therefore, the investigation is inconclusive as no evidence has been provided to confirm any alleged deficiency with the marker. The definitive root cause could not be determined based upon the available information. It is unknown whether procedural issues contributed to the event. Labeling review: the current ifu (instructions for use) states: indications: the ultracor twirl breast tissue marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or percutaneous breast biopsy to radiographically mark the location of the biopsy procedure. Contraindications: patients with a known hypersensitivity to the materials listed in the device description may suffer an allergic reaction to this implant. The implant is made from a nickel-titanium alloy; if there is a known allergy to nickel, use of the ultracor twirl breast tissue marker is not advised. Potential complications: potential complications of breast tissue marker placement may include, but are not limited to: hematoma, hemorrhage, infection, allergic reaction, adjacent tissue injury and pain. The information provided by bard represents all of 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 bard.
 
Event Description
It was reported that during a breast tissue marker deployment procedure, the marker allegedly caused arterial bleeding in the patient.
 
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer. The lot number for the device was not provided. The device has not been returned for evaluation. The investigation of the reported event is currently underway. The information provided by bard represents all of 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 bard.
 
Event Description
It was reported that during a breast tissue marker deployment procedure, the marker allegedly caused arterial bleeding in the patient.
 
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Brand NameULTRACOR TWIRL MARKER
Type of DeviceBREAST TISSUE MARKER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD SHANNON LIMITED
san geronimo industrial park
lot #1, road #3, km 79.7
humacao 00791
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7130441
MDR Text Key113923094
Report Number2020394-2017-01771
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K152510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUCTW17
Device Catalogue NumberUCTW17
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/19/2017 Patient Sequence Number: 1
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