MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRA BREAST TISSUE MARKER; BIOPSY INSTRUMENT

Model Number	SMEC10R
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that some time post breast biopsy marker placement, the device allegedly had a positioning failure and was difficult to be removed after the procedure.Another marker was used to complete the procedure, but unsuccessful.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one senomark biopsy marker applicator was returned for evaluation.During visual evaluation, the biopsy marker appeared to have blood residue.The wire-form marker and pads were not present in the returned applicator.Functional testing was not conducted due to the returned device condition.Then, the biopsy applicator tip was x-rayed, and it was noted the marker was not present.The pva pads that were removed from the encor probe were x-rayed and it was noted the marker was present.Therefore, the investigation is confirmed for the reported positioning failure as markers were present in the returned device.However, the investigation is inconclusive for the reported difficult to remove as functional testing was not performed.A definitive root cause for the alleged positioning failure and difficult to remove could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: g3, h6 (method).H11: h6 (result, conclusion).H11:section a through f - the information provided by bd 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 bd.H3 other text : see h10.
Event or Problem Description
It was reported that the device allegedly had a positioning failure and the device was difficult to be removed after the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during the procedure the device allegedly was difficult to remove.It was further reported that the marker allegedly had positioning failure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one senomark biopsy marker applicator was returned for evaluation.During visual evaluation, the biopsy marker appeared to have blood residue.The applicator tip was detached from the applicator body and the delivery tube was stretched and kinked throughout.The wire-form marker and pads were not present in the returned applicator.The biopsy applicator tip was x-rayed, and it was noted the marker was not present.The pva pads were found in the returned encor probe aperture behind blockage.Therefore, based on the received condition of the sample the investigation is confirmed for positioning failure, difficulty removing the applicator from the probe, a broken wireform, and detached applicator tip.Based upon the reported information and the returned sample condition (detached applicator tip, stretching of the applicator tubing) the identified detachment and break are consistent with excessive force used to remove a stuck applicator.The definitive root causes for the deployment and removal issues are unknown.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11: section a through f ¿ the information provide 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.

• Brand Name: SENOMARK ULTRA BREAST TISSUE MARKER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11899699
• Report Number: 2020394-2021-01126
• Device Sequence Number: 17248365
• Product Code: NEU
• UDI-Device Identifier: 00801741032035
• UDI-Public: (01)00801741032035
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SMEC10R
• Device Catalogue Number: SMEC10R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 08/05/2021; 10/21/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 08/09/2021; 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other