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

Catalog Number MC1820

Device Problems Failure to Prime (1492); Self-Activation or Keying (1557); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that after the first biopsy sample was obtained, the slides were difficult to lock into place and the device fired on its own without being triggered.Another device was used to complete the procedure.There was no reported patient or user injury.

Manufacturer Narrative

The lot number for the device has not been provided; therefore, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation is currently underway.

Manufacturer Narrative

The lot number was not reported, therefore, the device history records could not be reviewed.The investigation is inconclusive, as the sample was not returned for evaluation.Based upon the available information, the definitive root cause for this event is unknown.It is unknown whether procedural factors contributed to the event.The current ifu (instructions for use) states precautions - never test the product by firing into the air damage may occur to the needle/cannula tip and could result in patient and, or user injury - unusual force applied to the stylet or unusual resistance against the stylet while extended out of the supportive cannula may cause the stylet to bend at the specimen notch.A bent specimen notch ma, interfere with the needle function.Directions for use - energize (cock) instrument by pulling back on the top slide to withdraw the cannula and lock in place.Then pull back on the bottom slide to withdraw, the stylet and lock in place.Remove protective needle sheath and yellow guard instrument is ready to fire when both slides are locked back - verify instrument is energized (cocked).Note: do not place fingers in front of cocking slides once instrument is energized (cocked) impeding cocking slides' movement will impact functionality.Potential complications - potential complications associated with core biopsy procedures are site specific and include, but are not limited to hematoma, hemorrhage, infection, adjacent tissue injury, pain bleeding, hemoptysis, hemothorax, non-target tissue, organ or vessel perforation, and air embolism.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The user facility did not have any additional details to provide at this time.

• Brand Name: MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENTS
• 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: 4055397
• MDR Text Key: 4812614
• Report Number: 2020394-2014-00360
• 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: User Facility,health professional,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC1820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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