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

Model Number SMUC10H

Device Problems Break (1069); Nonstandard Device (1420); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2024).

Event Description

It was reported that during an ultrasound guided marker placement procedure, the device allegedly broken.It was further reported that broken segments still in patient.Patient current status unknown.

Manufacturer Narrative

H10: 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.Investigation summary: the physical device was not returned for evaluation.Two medical images were reviewed.The provided mammogram images demonstrate a mass within the left breast.The mass contains a post-biopsy breast tissue marker.As reported in the complaint, the marker does not demonstrate the expected shape of a heart.Though the ring is broken, the marker appears to remain in 1 piece and is in its expected location within the mass.The senomark ultracor heart-shaped breast tissue marker is made of titanium.However rarely, the ring structure can break, resulting in the marker no longer having a heart shaped appearance.This is of no clinical significance.If the biopsy results are malignant, the marker is still visible by both mammogram and ultrasound and can be targeted for wire localization if necessary.If the biopsy results are benign and the mass is not surgically removed, the marker can remain in the patient indefinitely, regardless of its shape.Based on the image review, break cannot be confirmed as there is no enough information to confirm that the wireform is broken.However, it is confirmed that the returned images do not show the correct wireform shape.Therefore, the investigation is confirmed for the identified non-standard device issue as the wireform shape was not in correct appearance in the returned images.However, the investigation is inconclusive for the reported break as there is no objective evidence.A definitive root cause for the alleged break and identified non-standard device could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 02/2024), g3, h6 (method).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.

Event Description

It was reported that during an ultrasound guided breast biopsy marker placement procedure, the device allegedly broken.It was further reported that broken device still in patient.The patient current status is unknown.

Event Description

It was reported that during an ultrasound guided breast biopsy marker placement procedure, the device allegedly broken.It was further reported that broken device still in patient.There was no reported patient injury.

Manufacturer Narrative

H10: additional information was received and the reportability was reassessed as malfunction.H10: 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.Investigation summary: the physical device was not returned for evaluation.Two medical images were reviewed.The provided mammogram images demonstrate a mass within the left breast.The mass contains a post-biopsy breast tissue marker.As reported in the complaint, the marker does not demonstrate the expected shape of a heart.Though the ring is broken, the marker appears to remain in 1 piece and is in its expected location within the mass.The senomark ultracor heart-shaped breast tissue marker is made of titanium.However rarely, the ring structure can break, resulting in the marker no longer having a heart shaped appearance.This is of no clinical significance.If the biopsy results are malignant, the marker is still visible by both mammogram and ultrasound and can be targeted for wire localization if necessary.If the biopsy results are benign and the mass is not surgically removed, the marker can remain in the patient indefinitely, regardless of its shape.Based on the image review, break cannot be confirmed as there is no enough information to confirm that the wireform is broken.However, it is confirmed that the returned images do not show the correct wireform shape.Therefore, the investigation is confirmed for the identified non-standard device issue as the wireform shape was not in correct appearance in the returned images.However, the investigation is inconclusive for the reported break as there is no objective evidence.A definitive root cause for the alleged break and identified non-standard device could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 02/2025), g3.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 ULTRACOR MARKER
• Type of Device: BIOPSY INSTRUMENT
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13041109
• MDR Text Key: 282635480
• Report Number: 2020394-2021-02086
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032394
• UDI-Public: (01)00801741032394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMUC10H
• Device Catalogue Number: SMUC10H
• Device Lot Number: VTFP00127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention