MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ELEVATION PROBE; BIOPSY INSTRUMENT

Model Number EV14

Device Problems Failure to Obtain Sample (2533); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2025) 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.H3 other text : device pending return.

Event Description

It was reported that during a breast biopsy procedure, the samples allegedly got stuck in the probe near the sample container, and the device allegedly had a filling problem.It was further reported that the samples could be taken out eventually using a thin needle, but a transparent foreign material was allegedly found.The possibility that this material is a tumor cannot be ruled out, and the physician has requested an in-hospital pathological test.There was no reported patient injury.

Event Description

It was reported that during a breast biopsy procedure, the samples allegedly got stuck in the probe near the sample container, and the device allegedly had a filling problem.It was further reported that the samples could be taken out eventually using a thin needle, and a transparent foreign material was allegedly found.The possibility that this material is a tumor cannot be ruled out, and the physician has requested an in-hospital pathological test.There was no reported patient injury.

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: one elevation breast biopsy probe was returned for evaluation.On visual evaluation, the device appeared to have residue throughout.Under microscopic observation, unknown-jelly like material was noted to the proximal end of the vacuum tube cannula.Prior to functional testing, cutting cannula was retracted and mandrel was inserted into the cannula; tissue was noted within.The probe was loaded onto the in-house driver and calibrated successfully.And it was also tested in a chicken breast, and the device was able to obtain six samples successfully.And it was also noted that the smart mode was activated while acquiring all six samples.Post to functional testing, cutting cannula was retracted and no tissue was noted within.Ftir testing was done on the unknown jelly like material and the results showed the jelly like material was noted to be a polymer due to its interaction with electron beam during sem examination.And it was noted that the particulate was a solid particle with features containing polymer fracturing.During the ftir spectra analysis of the sample, it was noted that the material showed correlation to manufacturing material (silopren e 3078).Also, one electronic photo was provided for review.Powerpoint attachment was provided, two photos were present in the document.First photo shows the end of the cannula where small transparent material is present.Second photo shows the transparent material present in the tissue which was marked.Therefore, based on the photo review, the reported failure device contamination with chemical or other material can be confirmed, based on the provided photo.However, the reported failure to obtain sample could not be confirmed.Based on the sample evaluation, the investigation is confirmed for the reported failure to obtain sample as the returned device had sample in the sample notch.(which was not transported to sample notch).Also, based on the sample evaluation the investigation is confirmed for the reported device contamination with chemical or other material is confirmed ftir results showed the material was consistent with manufacturing material.A definitive root cause for the device contamination with chemical or other material is determined to be manufacturing related.A definitive root cause for the alleged failure to obtain sample and device contamination with chemical or other material could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 12/2025), 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: ELEVATION PROBE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FERROSAN MEDICAL DEVICES SP. Z.O.O.; ul. koksowa 3; 70-031 szczecin ; PL
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17369804
• MDR Text Key: 319480899
• Report Number: 2020394-2023-00530
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741182396
• UDI-Public: (01)00801741182396
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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
• Device Operator: Health Professional
• Device Model Number: EV14
• Device Catalogue Number: EV14
• Device Lot Number: 91017721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• 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