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

Catalog Number F14105US

Device Problems Break (1069); Sticking (1597); Failure to Disconnect (2541)

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

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.

Event Description

It was reported that after successfully completing an ultrasound guided breast biopsy, the probe was allegedly stuck inside the driver.No patient injury reported.

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a review of the device history records cannot be performed.Visual inspection: the device has been returned to the manufacturer for evaluation.The probe was received loaded inside the driver.The cutting cannula was fully extended.The sample notch was retracted into the cutting cannula 15.2cm.No anomalies were noted to the probe.It was noted that the cannula driver was visible and that the driver service hatch was not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: in order to remove the probe from the driver, the lever was accessed through the bottom of the sample cup holder and as the lever was retracted, the probe was removed with no issues.The cannula driver was noted to be pushed in from the initial position.Once the probe was removed from the driver, it was observed that the lever was disengaged as expected for a used probe.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.The gears appeared to be out of alignment.The cutting cannula and sample notch were separated and it was found that the tooth rack was broken.It is unknown how or when the break occurred.Medical records review & image/photo review: no medical records or images/photos were provided; therefore, a review was not performed.Conclusion: the investigation is confirmed for failure to disconnect, as the probe was returned in the customer driver.The investigation is also confirmed for a break, as the tooth rack was found broke during evaluation.The broken tooth rack could lead to cycling issues which would lead to difficulty removing the probe from the driver.The root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review: the current instructions for use (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 adverse effects on components that are influenced by thermal and/or mechanical changes.Performing a biopsy remove the probe from the driver by pressing down on the locking tab, pushing the carriage completely forward and pulling the probe straight from the driver.The information provided by bard representatives, is all the known information provided at this time.Despite good-faith efforts to obtain additional information, the complaint/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: 5357396
• MDR Text Key: 35995368
• Report Number: 2020394-2016-00080
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2014

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 Catalogue Number: F14105US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2016
• 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