MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWIRL MARKER; BIOPSY INSTRUMENT

Model Number UCTW17

Device Problems Difficult to Remove (1528); Separation Failure (2547); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultracor breast biopsy marker was returned for evaluation.The marker appeared to be have blood residue on the tip of the marker.The marker system was returned in a pre-deployed configuration as the pusher was pulled back and the trigger was in the locked firing position.It was noted there was a slight bend to the cannula notch.The wireform was not returned for evaluation.No functional testing performed due to the condition of the device.Therefore, the investigation is confirmed for bent needle as the needle found to be bent.However, the investigation is inconclusive for separation failure and difficult to remove as the wireform was not returned along with the device and the used condition of the device on patient can not be replicated.A definitive root cause for the alleged separation failure, difficult to remove and bent needle could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 02/2023).

Event Description

It was reported that during a breast marker placement procedure, the device allegedly failed to deploy.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRACOR TWIRL MARKER
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11806673
• MDR Text Key: 250034715
• Report Number: 2020394-2021-01015
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741109416
• UDI-Public: (01)00801741109416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UCTW17
• Device Catalogue Number: UCTW17
• Device Lot Number: HUEP2889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2021
• 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
• Patient Outcome(s): Other