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

Model Number MC1610

Device Problems Failure to Prime (1492); Failure to Fire (2610); Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 12/2023).

Event Description

It was reported that during a breast biopsy procedure, the cannula allegedly failed to fire.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 maxcore disposable core biopsy instrument was received.Upon visual evaluation, the device was noted to have blood residue and the device was returned half primed, with the top slide pulled back and the bottom slide was in the initial position, leaving the sample notch exposed.There were no visual anomalies noted on the device.No visual anomalies were noted to the device components.Upon the function evaluation, the device was received at evaluation half primed.The bottom slide was pushed into the device and was able to lock into place, however it appeared that the top slide fired but was held into place by the bottom slide being primed.The top slide was held down and the side actuator button was able to fire the device.An attempt to prime the device by pushing the top slide into the device however, it was found that the top slide was able to freely move, and it would not lock into place.The device was disassembled, and internal parts were inspected.Upon disassembly, it was noted that a blue glove-like foreign material was wedged between the inner half -(left and right) assembly and the lower cocking slide (bottom slide) component.It was noted that the left and right bumper were slightly bent.It was noted that the stylet hub and cannula hub were from cavity 21.Therefore, the investigation for the identified failure to prime is confirmed as it was not primed during the evaluation and identified foreign material is confirmed as the foreign material is found between the inner half -(left and right) assembly and the lower cocking slide (bottom slide) component.The investigation for the reported failure to fire is inconclusive as it was not identified in sample evaluation.Per the evaluation results, a piece of latex glove was noted within the inner housing, affecting the components that control priming the device.This appears to be the result of the assembly process, as the material is consistent with the gloves used by operators during the assembly process and the inner housing is not accessible after assembly.The manufacturing site was notified of the event and issued an operator awareness training.Additional actions implemented by the site include acquisition of different glove sizes to ensure gloves fit all operators' hands snugly and forthcoming updates to assembly procedures to specify how the gloves should fit and to inspect for relevant damage during assembly.Based on the location of the identified glove material, it is likely that the identified material found within the device contributed to the reported and identified issues.However, the definitive root cause could not be determined based upon available 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: 12/2023), g3, h6 (device, 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 a breast biopsy procedure, the cannula allegedly failed to fire.It was further reported that foreign material allegedly identified.There was no reported patient injury.

• Brand Name: MAXCORE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12357833
• MDR Text Key: 267806409
• Report Number: 2020394-2021-01496
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084447
• UDI-Public: (01)00801741084447
• Combination Product (y/n): N
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC1610
• Device Catalogue Number: MC1610
• Device Lot Number: REFN1586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1