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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DT BREAST TISSUE MARKER

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BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DT BREAST TISSUE MARKER Back to Search Results
Catalog Number 864017D
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer. The lot number was not provided; therefore, the device history records could not be reviewed. The device is not available for return. The investigation 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 post tissue marker placement under mri imaging, there allegedly was a blooming artifact. There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be performed, as the lot number was unknown. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: no medical images were made available to the manufacturer. Conclusion: the investigation is inconclusive, as the samples were not returned for evaluation and images were not provided for review. Per the reported event details, the biopsy clip was visualized under mri imaging. The current ifu states, "mr image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the ultraclip dual trigger breast tissue marker. Therefore, it may be necessary to optimize mr imaging parameters for the presence of this metallic implant. " it is possible that procedural issues and/or imaging techniques contributed to the reported event. However, based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: the ultraclip dual trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (pva). The tissue marker, located inside the distal end of the introducer needle, is made of titanium, inconel 625 or biodur 108 and contains a pva polymer pellet interwoven with the marker to enhance viewing of the marker under ultrasound. Please note this polymer is non-absorbable. Indications for use: the ultraclip dual trigger breast tissue marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure. Mr conditional information: non-clinical testing has demonstrated that the tissue marker is mr conditional. It can be scanned safely under the following conditions: ¿ static magnetic field of 3-tesla or less ¿ spatial gradient filed of 720-gauss/cm or less ¿ maximum mr system reported whole-body-averaged specific absorption rate (sar) of 3-w/kg for 15 minutes of scanning. Mr image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the ultraclip® dual trigger breast tissue marker. Therefore, it may be necessary to optimize mr imaging parameters for the presence of this metallic implant. 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 post tissue marker placement under mri imaging, there allegedly was a blooming artifact. There was no reported patient injury.
 
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Brand NameULTRACLIP DT BREAST TISSUE 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 Key6105973
MDR Text Key60097631
Report Number2020394-2016-01061
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number864017D
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2016
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

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