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

Catalog Number F14105US

Device Problems Bent (1059); Device Damaged Prior to Use (2284); Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2013

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.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 breast biopsy procedure, probe was removed from packaging, placed in the driver and the driver went to green lights.The physician primed outside the patient and it was observed that there was no needle tip.Sales rep indicated that there was no needle tip found in the packaging.The procedure was completed with another probe.There was no patient involvement.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: the probe appeared to be clean.The lever was disengaged, as expected for a used probe.The main probe assembly was pushed back on the probe cover.The cannula driver was in its initial position.The slider was pulled out from the slider cover, indicating that the clutch wheel was not engaging the internal gears and that the probe was in prime/pierce mode.The sample notch was retracted 13.1cm into the cutting cannula and was sitting below the sample cup holder.It is unknown when or how the sample notch became retracted.The clutch wheel was out of alignment.It was observed that the tip of the cutting cannula was bent downwards.The damage to the cutting cannula likely happened post procedure during shipping or handling as it was not reported by the user.Performance/functional evaluation: the cannula driver was removed in order to examine the sample notch.Upon removal of the cutting cannula, it was noted that there was no tissue inside the sample notch and it was clean.The cutting cannula and sample notch were placed back in their initial positions.In order to recreate the reported conditions of use, the sample notch was retracted 13.1cm back into the cutting cannula.The slider and cannula driver were placed back in their initial positions.In order to load the probe into the driver, the clutch wheel was placed back into alignment and the lever was re-engaged.An in-house safety pin was pushed into the probe once all the components were aligned with the sample notch retracted 13.1cm into the cutting cannula.The probe was loaded into an in-house driver.The probe clicked into place and the driver lights flashed green, indicating that the probe was installed.The device primed and pierced successfully.The sample notch remained retracted within the cutting cannula throughout the prime/pierce sequence.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: one electronic (1) photo was received from the user facility and reviewed.The photo showed the cutting cannula inside the integrated cannula coaxial assembly.The sample notch was not observed in the photo.The photo was taken next to the product labeling.No conclusions could be made regarding the reported missing sample notch, as the inside of the cannula cannot be observed in the photo.Conclusion: the investigation is unconfirmed for a detachment, as the sample notch was found to be attached and retracted into the cutting cannula.The investigation is confirmed for a bent cutting cannula tip.The root cause could not be determined based upon available information.It is unknown whether procedural factors contributed to the event.It is unknown when or how the tip of the cutting cannula became bent.Labeling review: the current instructions for use (ifu) 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: 5352492
• MDR Text Key: 35683199
• Report Number: 2020394-2016-00012
• 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: 06/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: F14105US
• Device Lot Number: 91000788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2012
• 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