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

Model Number MC1820

Device Problem Failure to Obtain Sample (2533)

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

Event Date 06/04/2023

Event Type  malfunction  

Event Description

It was reported that during an ultrasound-guided kidney biopsy through normal-density tissue, the device allegedly failed to obtain samples.A coaxial was not used.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: a voluntary recall was issued for the max-core disposable core biopsy instrument for specific product code/lot number combinations.The affected product code/lot number combinations may be at risk of having firing issues.An example of a firing issue is where the device does not completely fire, resulting in the inability to obtain tissue samples.A root cause investigation and field action determination was conducted as a result of an increase in complaints for failure to fire, firing problem, and failure to obtain samples.The investigation included an extensive manufacturing review, risk documentation review for the three reported malfunctions, and evaluations performed on the returned devices.The root cause for the increase in complaints was related to mold maintenance that was performed on the cannula over-mold for mold 3.That maintenance had the unintended consequence of impacting product performance in specific low frequency use situations.The change made to mold 3 increased the spacing between the locking and unlocking mechanisms of the device, resulting in a reduction in stored energy within the device.This, in combination with the density of the tissue being biopsied, can occasionally result in issues where the device does not fully fire when the trigger is pressed (i.E.Only the stylet fires).All lots manufactured after the maintenance on mold 3 was performed are included in the scope of the recall.All reported complaints from the affected product code/lot number combinations that are possibly related to the firing issue have been classified as failure to fire, firing problem, or failure to obtain samples.This reported complaint is from an affected lot number that was reported for one of these firing issues.H10: d4 (expiry date: 05/2022).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 : device not returned.

Event Description

It was reported that during an ultrasound-guided kidney biopsy through normal-density tissue, the device allegedly failed to obtain samples.A coaxial was not used.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: additional information was received, the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 07/2025), g3.H11: d4 (medical device lot number).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 not returned.

• Brand Name: MAXCORE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17223714
• MDR Text Key: 318083998
• Report Number: 2020394-2023-00462
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084485
• UDI-Public: (01)00801741084485
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133948
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

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: MC1820
• Device Catalogue Number: MC1820
• Device Lot Number: REGW0168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 07/22/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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