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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GELMARK ULTRA BIOPSY SITE MARKER BREAST TISSUE MARKER

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BARD PERIPHERAL VASCULAR, INC. GELMARK ULTRA BIOPSY SITE MARKER BREAST TISSUE MARKER Back to Search Results
Model Number GMUEC10GSS
Device Problems Break (1069); Difficult to Insert (1316); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Activation, Positioning or SeparationProblem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2017
Event Type  malfunction  
Manufacturer Narrative
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. This is the only complaint reported to date for this lot number and failure mode. Investigation summary: the gelmark ultra marker was not returned for evaluation; images were provided and reviewed. Based on the image review, the reported foreign material and deployment issues could not be confirmed. Therefore, the investigation is inconclusive for the reported insertion and removal difficulties, foreign material, and deployment issues, as the device was not returned and the image review could not confirm the alleged issues. The definitive root cause for the reported foreign material, deployment issue, or insertion and removal difficulties could not be determined based upon the available information. It is unknown whether procedural issues contributed to the event. Labeling review: the current gelmark ultra breast tissue marker instructions for use (ifu) states: general information and device description: the marker consists of 11 resorbable polylactiv acid/polyglycolic acid (pla/pga) pads with one embedded radiopaque wireform. The wireform is intended for long-term radiographic marking of the biopsy site. The pellets are visible via ultrasound for approximately 6 weeks and are essentially resorbed in approximately 12 weeks. The syringe-like applicator fits within the encor probe to access the biopsy cavity. Precautions: the device should only be used by physicians trained in the percutaneous biopsy procedures. Do not use this product if the sterile barrier has been previously opened or if the package is damaged. Maintain correct alignment of the yellow indicator key with the red arrow of the biopsy probe when dispensing pellets. Complications: potential complications that may be associated with the use of gelmark ultra biopsy site marker are similar to those associated with the use of other biopsy marking devices. Directions for use: remove the port cap from the sample chamber of probe. Insert tip guide into sample chamber. Ensure the tip guide is fully inserted. Insert the applicator through the tip guide into the biopsy probe. Advance the applicator to align the yellow indicator with the red arrow of the biopsy probe. Immediately deploy all pellets by advancing the plunger. Rotate the biopsy device 180 degrees to position the sample chamber away from the dispensed pellets. Remove the applicator from the biopsy device. (b)(4).
 
Event Description
It was reported that during breast tissue marker placement, the marker applicator was allegedly difficult to insert into the probe and the marker was able to be placed. It was further reported under post procedure imaging the marker was placed approximately 1-2 cm from the biopsy site and a small foreign object was observed. It was further reported the probe and marker were removed as one unit and the marker applicator was unable to be removed from the probe. There was no reported patient injury.
 
Event Description
It was reported that during breast tissue marker placement, the marker applicator was allegedly difficult to insert into the probe and the marker was able to be placed. It was further reported under post procedure imaging the marker migrated approximately 1-2 cm from the biopsy site and a small foreign object was observed. Reportedly, the small piece observed is a piece of the marker that may have broken off into the patient. It was further reported the probe and marker were removed as one unit and the marker applicator was unable to be removed from the probe. There was no reported patient injury.
 
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Brand NameGELMARK ULTRA BIOPSY SITE MARKER
Type of DeviceBREAST TISSUE MARKER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
INFUS MEDICAL (THAILAND)
706 moo 4
bangpoo ind estate
samutprakarn province 10280
TH 10280
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key6792467
MDR Text Key253518752
Report Number2020394-2017-00961
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K040706
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2017
Device Model NumberGMUEC10GSS
Device Catalogue NumberGMUEC10GSS
Device Lot NumberVTAX00570
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 Received11/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2016
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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