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

Catalog Number MC1825

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Failure to Obtain Sample (2533)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 02/2021).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 prostate biopsy in normal density tissue, the needle of the device was allegedly difficult to remove from the patient, allegedly difficult to reinsert into the patient, and allegedly failed to obtain samples intermittently.A coaxial was used and another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(added fda device code 2533 failure to obtain samples).

Event Description

It was reported that during an ultrasound-guided prostate biopsy in normal density tissue, the needle of the device was allegedly difficult to remove from the patient, allegedly difficult to reinsert into the patient, and allegedly failed to obtain samples intermittently.A coaxial was used and another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: 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
• MDR Report Key: 7657072
• MDR Text Key: 113003091
• Report Number: 2020394-2018-01064
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084492
• UDI-Public: (01)00801741084492
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC1825
• Device Lot Number: RECP1989
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1