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

Model Number MQ1410

Device Problems Break (1069); Failure to Obtain Sample (2533); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/11/2021

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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd- (b)(6).(expiry date: 05/2023).

Event Description

It was reported that during an ultrasound-guided breast biopsy procedure, the device allegedly failed to obtain samples.A coaxial was not used.There was no reported patient injury.

Manufacturer Narrative

H10: a voluntary recall has been initiated for the bard® marquee® disposable core biopsy instruments and instrument kits which was product catalog/lot number specific.Reportedly the penetration depth switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.The penetration depth switch detachments may result in (1) prolongation of the biopsy procedures as the user obtains a replacement device, (2) undershooting the lesion unsuspectedly, compromising the sample quality and potentially leading to a misdiagnosis (3) or if the penetration is overshot, the device may pierce adjacent tissue and/or organs causing injury.To date, there have been no reported patient injuries associated with these penetration depth switch detachments.As a result of the field action, this event is being reported as a malfunction reportable event.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found within the dhr review to indicate there was a manufacturing related cause for this event.Investigation summary: one marquee disposable core biopsy instrument has been received.On visual evaluation, the sample appeared to be clean and penetration depth marker was set to 25mm.Upon functional testing, the device was able to be fully primed with no issues.The device was further tested by cocking and firing the device 12 times at the 18mm and 25mm into a pork shoulder using the automatic and semiautomatic firing options.The device was able to prime and fire properly.All 24 samples were obtained.During functional testing the depth adjustment plate popped off from the device.Therefore, the investigation is unconfirmed for the reported failure to obtain sample as 24 samples were obtained.However, the investigation is confirmed for the identified break of the depth penetration knob as it is popped off from the device during functional evaluation.An external investigation concluded that the root cause is manufacturing related, as a fixture that assembles this part was missing a pin on one side.This resulted in a gap between the knob and the depth plate/housing that resulted in the reported issue.The definitive root cause for the reported failure to obtain sample could not be determined based upon the 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: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for this product is bd-santo domingo.H10: d4 (expiry date: 05/2023).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.

Event Description

It was reported that during an ultrasound-guided breast biopsy procedure, the device allegedly failed to obtain samples.A coaxial was not used.There was no reported patient injury.

• Brand Name: MARQUEE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11524967
• MDR Text Key: 240940418
• Report Number: 2020394-2021-00612
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741097133
• UDI-Public: (01)00801741097133
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MQ1410
• Device Catalogue Number: MQ1410
• Device Lot Number: 0001364077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: UNKNOWN
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 71