MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FINESSE ULTRA 10G PROBE

Catalog Number F10105US

Device Problems Break (1069); Failure to Reset (1532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2013

Event Type  malfunction  

Manufacturer Narrative

After further clinical review of this event with bard's medical department, this event was reassessed and determined to be mdr reportable as a malfunction pursuant to 21cfr part 803.A manufacturing review could not be performed, as the lot number is unknown.One finesse ultra 10g probe was returned for evaluation.Only a portion of the toothed rack was returned and the remaining pieces including the sample notch were not included with the returned sample.The break was located 55mm from the distal end of the vacuum rib.The returned broken toothed rack length was measured and found to be 136 mm.Therefore, approximately 73mm were broken off and not returned for evaluation.The investigation is confirmed for a broken toothed rack.As a result of the fractured toothed rack, functional testing could not be performed.The definitive root cause could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.The finesse biopsy probe instructions for use (ifu) provides general instructions for priming, firing, sampling and retrieval of samples from 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.

Event Description

It was reported that during an ultrasound guided breast biopsy procedure into dense tissue, the device went to one solid orange light on the third pass and two samples were obtained.The device was removed from the patient and it was observed a piece of the device broke off.The device was not able to reset by holding the prime/pierce and sample buttons and the needle is stuck on the driver.The procedure was completed with another biopsy device.There was no patient injury reported.

• Brand Name: FINESSE ULTRA 10G PROBE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): FERROSAN MEDICAL DEVICES SP. Z.O.O.; ul. koksowa 3; szczecin 70-03 1; PL 70-031
• Manufacturer Contact: christina hayes ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 5007187
• MDR Text Key: 23553519
• Report Number: 2020394-2015-01179
• 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: Other
• Report Date: 04/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: F10105US
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2015
• 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