MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT

Catalog Number MC1820

Device Problems Bent (1059); Dull, Blunt (2407); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.The device has been returned to the manufacturer for evaluation.As the lot number for the device was provided, a review of the device history records is currently being performed.The investigation of the reported event is currently underway.

Event Description

It was reported that during an ultrasound-guided prostate biopsy, the tip of the device allegedly broke off outside of the patient.It was further reported that the procedure was completed with another device.There was no reported patient injury.

Manufacturer Narrative

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 biopsy needle was returned for evaluation.The investigation is confirmed for a bent needle, as the sample notch bend was found to be out of specification.The investigation is also confirmed for a dull needle, as the tip appeared blunted under magnification.The investigation is inconclusive for the alleged tip detachment, as there was no clear detachment found during investigation and no detached fragment was returned.Per the evaluation results, the distal tip of the needle was identified to be dull and no portion of the needle was found to be detached.The user most likely identified the dulled needle tip as a detachment.The sample notch was also identified to be bent throughout the length.Therefore, the needle most likely experienced some force on the distal tip which contributed to the dulling and bending of the needle.Additionally, patient and/or procedural factors could have contributed to both the alleged and identified issues.All maxcore needles are visually inspected before and after assembly at manufacturing.Therefore, it is unlikely that a manufacturing related issue contributed to the reported issue.However, the definitive root cause is unknown.Labeling review: directions for use: bard® max-core® biopsy instrument preparation: before using, inspect the needle for damaged point, bent shaft or other imperfections that would prevent proper function.If the needle is damaged or bent, do not use.Using aseptic technique, remove the instrument from its package.To remove the protective needle sheath and yellow guard, you must energize (cock) instrument.

Event Description

It was reported that during an ultrasound-guided prostate biopsy, the tip of the device allegedly broke off outside of the patient.It was further reported that the procedure was completed with another device.There was no reported patient injury.

• Brand Name: BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT
• 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.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6992139
• MDR Text Key: 91212449
• Report Number: 2020394-2017-01478
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084485
• UDI-Public: (01)00801741084485
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: MC1820
• Device Lot Number: REBU1732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• 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 Age: 63 YR