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

Catalog Number MC1810

Device Problems Bent (1059); Failure to Prime (1492); Self-Activation or Keying (1557)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during an ultrasound-guided liver biopsy into normal tissue the device allegedly failed to prime and allegedly self-activated in formalin.It was further reported that the procedure was completed with the same device.There was no report of patient injury.

Manufacturer Narrative

Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Visual/microscopic inspection: the device was returned half primed, with the top slide pulled back and the bottom slide was in the initial position.There were no visual anomalies noted on the device.The cannula and stylet were found bent to the right when positioned on a flat surface.The bent started approximately 0.894" from the base of the needle.The sample notch was also found to be bent backwards when positioned on a flat surface.The bent started approximately 0.169" from the base of the sample notch.It is unknown when and/or how the bend occurred.Performance/functional evaluation: unable to functionally test the device due to the bent needle and sample notch.Dimensional evaluation: measurement taken under magnification (10x).The notch thickness of the sample was measured and found to be within specification.However, the notch bend was measured, and was found not to be within the acceptable range.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is confirmed for bend, as the needle was found to be bent.However, the investigation is inconclusive for self-activation, as the device could not be functionally tested due to the bent needle.During sample evaluation, the needle was found to be bent which could have contributed to the self-activation issue.All maxcore needles are visually inspected for bends before and after assembly at manufacturing.Therefore, it is unlikely that the root cause is manufacturing related.Furthermore, it is unknown whether shipping and/or handling issues contributed to the event.The definitive root cause could not be determined based upon available information.Labeling review: the current maxcore instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.The information provided by bard 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 bard.

Manufacturer Narrative

Conclusion: the investigation is confirmed for bend, as the needle was found to be bent.However, the investigation is inconclusive for self-activation and failure to prime, as the device could not be functionally tested due to the bent needle.During sample evaluation, the needle was found to be bent which could have contributed to the self-activation issue.All maxcore needles are visually inspected for bends before and after assembly at manufacturing.Therefore, it is unlikely that the root cause is manufacturing related.Furthermore, it is unknown whether shipping and/or handling issues contributed to the event.The definitive root cause could not be determined based upon available information.Conclusion (added the reported issue "failure to prime").The information provided by bard 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 bard.

• Brand Name: MAXCORE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 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 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5572069
• MDR Text Key: 43032823
• Report Number: 2020394-2016-00354
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: MC1810
• Device Lot Number: REZL2371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• 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: 38 YR
• Patient Weight: 102