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

Catalog Number MC1816

Device Problems Bent (1059); Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number of the device was provided.The device history records are currently under review.The device has been returned 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 kidney biopsy, the tip of the needle allegedly became bent inside of the tissue.It was further reported that the needle was allegedly difficult to remove from the tissue; however, was able to be removed without issue.The procedure was completed with another device and a coaxial was not used.There was no reported patient injury.

Manufacturer Narrative

The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.One maxcore biopsy needle was returned for evaluation.The investigation was confirmed for bent, as the sample notch was found to be bent.The investigation was also confirmed for material fragmentation, as skiving was noted on the sample notch.The investigation was inconclusive for the reported difficulty removing from the tissue, as the device could not be fully functionally tested due to the needle bend and the conditions of the reported event could not be replicated.Labeling review: the current ifu (instructions for use) states: warnings: note: if collecting multiple samples, inspect the needle for damaged point, bent shaft or other imperfections after each sample is collected.Do not use needle if any imperfection is noted.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 may interfere with the needle function.Directions for use: bard max-core biopsy instrument preparation: before using, inspect the needle for damaged point, bent shaft or other imperfections that would prevent proper function.If the needle is damaged or bent, do not 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.Recommendation: for ease of insertion, puncture the skin with a scalpel at the entry site.Biopsy procedure: verify instrument is energized (cocked).Insert tip of needle to the point to be biopsied.While maintaining instrument's position and the needle orientation, depress the rear actuator button, or push the side actuator forward (direction of arrow), to cause both stylet and cannula to automatically advance.Remove needle from patient and pull back on the top slide to withdraw the cannula and expose the biopsy specimen.Remove the specimen.If additional biopsies are required, pull back on the bottom slide to withdraw the stylet and repeat the procedure.

Event Description

It was reported that during an ultrasound guided kidney biopsy, the tip of the needle allegedly became bent inside of the tissue.It was further reported that the needle was allegedly difficult to remove from the tissue; however, was able to be removed without issue.The procedure was completed with another device and a coaxial was not used.There was no reported patient injury.

• Brand Name: BARD 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
• 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: 6853793
• MDR Text Key: 85927588
• Report Number: 2020394-2017-01101
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084478
• UDI-Public: (01)00801741084478
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: MC1816
• Device Lot Number: REAW1611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2016
• 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