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

Catalog Number UNK FINESSE

Device Problems Difficult to Remove (1528); Failure to Reset (1532); Failure to Disconnect (2541); 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 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 sims biopsy driver took two samples could be processed, but by third run the device stuck into the breast and couldn't be removed.The device were removed with force from the breast, could not be reset and the probe could not be disconnected from the instrument.It is unknown how the procedure was completed.There was no patient injury reported.

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as lot number was unknown.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.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: the current instructions for use (ifu) states: 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.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: 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.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 BIOPSY 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: 5353860
• MDR Text Key: 35735097
• Report Number: 2020394-2016-00018
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: K093068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2012

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: UNK FINESSE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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