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 Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation is currently underway.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.

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 inspection: the sample was returned.Both slides were in their initial position.The cannula and stylet were found bent to the right when positioned on a flat surface.The bent started approximately 2.99" from the base of the needle.It is unknown when and/or how the bend occurred.The top slide was pulled back and the no anomalies were noted to the sample notch.Performance/functional evaluation: functional testing could not be performed due to the bent needle.Dimensional evaluation: the notch thickness of the sample was measured and found to be within specification.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

Manufacturing review: a manufacturing review was performed.The lot met all release criteria.X-ray: the returned maxcore device was examined via x-ray imaging prior to functional testing.The image attached shows the left side bumper to be missing within the device.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 left side bumper was found to be missing which could have contributed to the reported priming issue; however, the definitive root cause for the reported event could not be determined based upon available information.Additionally, sample evaluation found the needle to be bent.It is unclear when the needle became bent, as the issue was not reported by the user.As all maxcore needles are visually inspected for bends before and after assembly at manufacturing, it is unlikely that the root cause for the bent needle is manufacturing related.It is unknown whether shipping and/or handling issues contributed to the bend.(b)(4).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 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: 5571776
• MDR Text Key: 42500203
• Report Number: 2020394-2016-00351
• 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: 03/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2016
• 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: 50 YR
• Patient Weight: 127