MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT; PROSTATE BIOPSY DEVICE / INSTRUMENT, BIOPSY

Model Number MC1820

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2018

Event Type  malfunction  

Event Description

While the surgeon was attempting to obtain a prostate biopsy using the bard max-core disposable core biopsy instrument, upon attempted activation of the device, the device wasn't deploying as usual, and therefore no specimen was able to be obtained.

• Brand Name: MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT
• Type of Device: PROSTATE BIOPSY DEVICE / INSTRUMENT, BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR; tempe AZ 85281
• MDR Report Key: 7681270
• MDR Text Key: 113878377
• Report Number: MW5078341
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: MC1820
• Device Catalogue Number: MC1820
• Device Lot Number: RECS1720
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR