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

Catalog Number F14105US

Device Problems Difficult to Remove (1528); Failure to Disconnect (2541); Device Displays Incorrect Message (2591)

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

Event Date 12/19/2013

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 not 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 the physician fired into the lesion (fatty breast), pressed the sample button and after sampling the device went into orange lights mode/orange lights flashing simultaneously.The physician tried to disconnect the probe from the coaxial but was unsuccessful.Physician had to forcefully pull the probe out of the breast and was able to retrieve the specimen from the probe.Completed the procedure with a another probe.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.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 investigation is inconclusive, as the probe was not returned for evaluation.Per the event description, it was noted that the breast tissue was fatty; therefore it is possible that patient factors contributed to the event.However, the definitive root cause could not be determined based upon available information.Labeling review: the current instructions for use (ifu) states: precautions 1.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.2.The finesse® ultra breast biopsy system should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.Potential complications 1.Potential complications are those associated with any percutaneous removal/ biopsy technique for tissue collection.Potential complications are limited to the region surrounding the biopsy site and include hematoma, hemorrhage, infection, a non-healing wound, pain and tissue adherence to the biopsy probe while removing it from the breast.2.As per routine biopsy procedures, it may be necessary to cut tissue adhering to the biopsy probe while removing it from the breast.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 INSTURMENT
• 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: 5352483
• MDR Text Key: 35676557
• Report Number: 2020394-2016-00009
• 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
• Reporter Occupation: Medical Technologist
• 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: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: F14105US
• Device Lot Number: 91003575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2013
• 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