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

Catalog Number F14105US

Device Problems Break (1069); Difficult to Remove (1528); Failure to Reset (1532); Reset Problem (3019)

Patient Problem No Consequences Or Impact To Patient (2199)

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 not provided, a review of the device history records cannot be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event 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 a breast biopsy procedure, on the third sample acquisition, the driver errored.An attempt was made to reset the error; however, the driver could not be reset and the probe could not be removed from the driver.The procedure was completed with the samples obtained.There was no patient injury reported.

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.Visual/microscopic inspection: the device was returned used.The probe was received loaded inside the driver.The cutting cannula was fully extended.The sample notch retracted approximately 16.5 cm into the cutting cannula.It was noted that the cannula driver was visible and that the driver service hatch was not restricting the probe¿s removal.It appeared as though the lever was still engaged with the driver¿s lever motor/probe interface.This would lead to difficulty removing the probe from the driver, as the probe lever would need to be released while extracting the probe.Functional/performance evaluation: the lever was disengaged upon removal from the driver.The cannula driver was in its initial position.The slider was pulled out, indicating that the clutch wheel was not engaging the internal gears, and that the probe was in prime pierce mode.The gears were out of alignment.In order to functionally test the probe, the lever was reengaged.The probe was loaded into the customer's driver.The probe clicked into place and the driver lights flashed green.The device was then primed and pierced.An attempt to take a sample resulted in the sample notch retracting into the sample cup, and flashing red lights.The probe was unable to be reset in the driver.The probe was removed from the driver, and the driver was reset.The probe was removed from the driver and disassembled completely, where it was found that the connecting slot of the toothed rack was broken off at the spiraled groove.As a result, further testing could not be completed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion:the compliant investigation is confirmed for failure to reset due to a broken toothed rack.The root cause for the reported failure to reset can be attributed to the toothed rack fracturing during cycling.However, the cause for the broken toothed crack could not be determined.It is unknown whether procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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: 5353950
• MDR Text Key: 35809146
• Report Number: 2020394-2016-00021
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: F14105US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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