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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRA BREAST TISSUE MARKER
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BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRA BREAST TISSUE MARKER Back to Search Results
Catalog Number SMMA11R
Device Problems Difficult to Insert (1316); Cut In Material (2454); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 02/04/2015
Event Type  malfunction  
Event Description
It was reported that during ultrasound-guided breast tissue marker placement, there was resistance felt during insertion of the marker.The marker was deployed and the marker applicator was removed with the probe.The imaging showed part of the tip detached in the breast tissue.There was no reported pt injury.
 
Manufacturer Narrative
The lot number for the device has been provied.A review of the device history records is currently being performed.The device has been returned to the mfr for eval.The investigation is currently underway.
 
Manufacturer Narrative
A manufacturing review was completed.The lot met all release criteria.One senomark ultra marker applicator was returned for eval.The investigation is confirmed for cut material, as the distal tip was found to have been cut from the applicator.Per the reported event details, there was resistance felt during insertion of the applicator into the probe.It is possible that this resistance contributed to the severed applicator tip.However, the definitive root cause could not be determined based upon available info.It is unk whether pt and/or procedural issues contributed to the event.The current ifu states warnings: avoid the use of excessive force during removal of the applicator to prevent breakage of the applicator tip.
 
Event Description
It was reported that during ultrasound-guided breast tissue marker placement, there was resistance felt during insertion of the marker.The marker was deployed and the marker applicator was removed with the probe.The imaging showed part of the tip detached in the breast tissue.There was no reported patient injury and the detached piece was not scheduled to be removed.
 
Manufacturer Narrative
Multiple f/u attempts were made to obtain any info pertaining to the pt, product, and/or procedural details (e.G., date of the event, relevant test data, relevant history, lot number, catalog number, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The international rep did not have any add'l details to provide at this time.
 
Manufacturer Narrative
Upon further evaluation, it was determined that supplemental follow-up #2 was erroneously submitted as follow-up #3.Therefore, follow-up #3 is being submitted to capture this correction.Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Investigation summary: one senomark ultra marker applicator was returned for evaluation.The investigation is confirmed for cut material, as the distal tip was found to have been cut from the applicator.Per the reported event details, there was resistance felt during insertion of the applicator into the probe.It is possible that this resistance contributed to the severed applicator tip.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings: - avoid the use of excessive force during removal of the applicator to prevent breakage of the applicator tip.Directions for use: - insert the applicator into the biopsy probe.Advance the applicator until the applicator contacts the distal end of the biopsy probe.- align the yellow indicator key with the white arrow on the thumbwheel of the biopsy probe.- immediately deploy all pads by advancing the plunger.The pads will be fully dispensed when the plunger contacts the applicator handle.- rotate the biopsy probe 180° to position the sample notch away from the dispensed pads.- remove the applicator from the biopsy probe.Avoid the use of force.
 
Event Description
It was reported that during ultrasound-guided breast tissue marker placement, there was resistance felt during insertion of the marker.The marker was deployed and the marker applicator was removed with the probe.The imaging showed part of the tip detached in the breast tissue.There was no reported patient injury and the detached piece was not scheduled to be removed.
 
Event Description
It was reported that during ultrasound-guided breast tissue marker placement, there was resistance felt during insertion of the marker.The marker was deployed and the marker applicator was removed with the probe.The imaging showed part of the tip detached in the breast tissue.There was no reported patient injury and the detached piece was not scheduled to be removed.
 
Manufacturer Narrative
H10: the previously submitted supplemental emdr inaccurately reported the g4 date of 09/15/2017.The g4 date on the supplemental should have been reported as 10/16/2017 upon further evaluation, it was determined that supplemental follow-up #2 was erroneously submitted as follow-up #3.Therefore, follow-up #3 was submitted to capture this correction.Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 for this lot number and issue to date.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Investigation summary: one senomark ultra marker applicator was returned for evaluation.The investigation is confirmed for cut material, as the distal tip was found to have been cut from the applicator.Per the reported event details, there was resistance felt during insertion of the applicator into the probe.It is possible that this resistance contributed to the severed applicator tip.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings: avoid the use of excessive force during removal of the applicator to prevent breakage of the applicator tip.Directions for use: insert the applicator into the biopsy probe.Advance the applicator until the applicator contacts the distal end of the biopsy probe.Align the yellow indicator key with the white arrow on the thumbwheel of the biopsy probe.Immediately deploy all pads by advancing the plunger.The pads will be fully dispensed when the plunger contacts the applicator handle.Rotate the biopsy probe 180° to position the sample notch away from the dispensed pads.Remove the applicator from the biopsy probe.Avoid the use of force.
 
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Brand Name
SENOMARK ULTRA BREAST TISSUE MARKER
Type of Device
BREAST TISSUE MARKER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key4611912
MDR Text Key22248165
Report Number2020394-2015-00134
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
PMA/PMN Number
K123911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative,for
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2015
Device Catalogue NumberSMMA11R
Device Lot NumberVT14G0272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2015
Date Manufacturer Received06/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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