MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FINESSE ULTRA 14G PROBE; BIOPSY INSTRUMENT

Catalog Number F14105US

Device Problems Break (1069); Failure to Reset (1532); Retraction Problem (1536); Failure to Disconnect (2541)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2013

Event Type  malfunction  

Manufacturer Narrative

A further clinical review of the event details was completed and a change in the mdr reportability was identified.No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during preparation for a breast biopsy, the needle was loaded into the driver to demonstrate to the patient the sounds to expect during the procedure.During the sampling sequence, the inner needle did not return to its starting position.When trying to remove the needle from the driver the needle appeared to be stuck and was not detachable from the driver.There was no patient involvement.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.The lot met all release criteria.Visual/microscopic inspection: the probe was received loaded inside the driver.The main probe assembly was pushed back onto the probe cover.The sample notch was partially retracted into the cutting cannula, and as a result, the gears were out of alignment.Functional/performance evaluation: the probe was returned clean.Once the probe was removed, it was observed that the driver had tried to reset with the probe inside, as the lever motor driver/probe interface was in its initial position and as a result, allowed the disengaged lever on the probe to remain engaged into the driver.The slider was in its initial position, indicating that the clutch wheel was engaging the internal gears, and that the probe was in sample acquisition mode.Additionally, the gears were out of alignment due to the retracted sample notch.In order to functionally test the probe, the cannula driver and slider assembly were removed to straighten the toothed rack.However, the toothed rack was found to be fractured.As a result of the broken toothed rack, functional testing could not be performed.The cover plate was removed to locate the fractured portion of the toothed rack and it was observed that the gears were not damaged and out of alignment.The root cause for the failure to reset is likely due to the broken toothed rack that caused the system to error in the manner reported by the customer.Medical records & image/photo review: no medical records or images/photos were provided for review.Conclusion: the investigation is confirmed for a broken toothed rack.As a result of the fractured toothed rack, functional testing could not be performed.However, the fractured toothed rack likely caused the system to error in the manner reported by the user.Per the finesse driver ifu, "do not demonstrate sample acquisition sequence in air prior to performing a biopsy procedure.Damage may occur to the needle or cannula tip." the root cause for the reported failure to reset can be attributed to the toothed rack fracturing during the sample cycle.However, the cause for the broken toothed rack could not be determined.It is unknown whether procedural issues contributed to the event.Labeling review: the current finesse probe ifu states: warnings:do not resterilize finesse® ultra biopsy probes.After resterilization, the sterility of the probe is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications.Cleaning, reprocessing and/or resterilizing the probe increases the probability that it will malfunction due to potential mechanical changes.Precautions: do not use the finesse® ultra biopsy probe without the integrated coaxial cannula.The integrated coaxial cannula may be removed after the biopsy to retain a track to the biopsy site when placing a tissue marker.Note: once a probe has been removed from the driver following a procedure, the probe cannot be re-inserted.If additional tissue samples are required, insert a new probe into the driver.Note: driver will initiate mechanical reset following probe removal.Do not insert a new probe prior to completion of this reset.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: FINESSE ULTRA 14G PROBE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FERROSAN MEDICAL DEVICES SP. Z O.O; ul. koksowa 3; 70-031 szczecin ; PL
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5358703
• MDR Text Key: 35996126
• Report Number: 2020394-2016-00107
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: F14105US
• Device Lot Number: 90005512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2012
• 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