MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWIRL MARKER; BREAST TISSUE MARKER

Model Number UCTW17

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was not provided.The device has not been returned 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 a breast tissue marker deployment procedure, the marker allegedly caused arterial bleeding in the patient.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not returned.No photos or images were provided for review.Therefore, the investigation is inconclusive as no evidence has been provided to confirm any alleged deficiency with the marker.The definitive root cause could not be determined based upon the available information.It is unknown whether procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: indications: the ultracor twirl breast tissue marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.Contraindications: patients with a known hypersensitivity to the materials listed in the device description may suffer an allergic reaction to this implant.The implant is made from a nickel-titanium alloy; if there is a known allergy to nickel, use of the ultracor twirl breast tissue marker is not advised.Potential complications: potential complications of breast tissue marker placement may include, but are not limited to: hematoma, hemorrhage, infection, allergic reaction, adjacent tissue injury and pain.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 a breast tissue marker deployment procedure, the marker allegedly caused arterial bleeding in the patient.

• Brand Name: ULTRACOR TWIRL MARKER
• Type of Device: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7130441
• MDR Text Key: 95262616
• Report Number: 2020394-2017-01771
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741109416
• UDI-Public: (01)00801741109416
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K152510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UCTW17
• Device Catalogue Number: UCTW17
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• 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
• Patient Outcome(s): Other