MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DUAL TRIGGER BREAST TISSUE MARKER

Catalog Number UNK ULTRACLIP DT

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 11/12/2016

Event Type  malfunction  

Manufacturer Narrative

Sakamoto, n., ogawa, y., tsunoda, y., & fukuma, e.(2016).Evaluation of the sonographic visibility and sonographic appearance of the breast biopsy marker (ultraclip) placed in phantoms and patients.The japanese breast cancer society, 24, 585-592.Doi 10.1007/s12282-016-0741-0 no hospital/medical records have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records will not 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 in an article in the japanese breast cancer society titled "evaluation of the sonographic visibility and sonographic appearance of the breast biopsy marker (ultraclip) placed in phantoms and patients", following mastectomy, during pathologic examination, foreign body reaction was observed.The current patient status was not provided.

Manufacturer Narrative

Sakamoto, n., ogawa, y., tsunoda, y., & fukuma, e.(2016).Evaluation of the sonographic visibility and sonographic appearance of the breast biopsy marker (ultraclip) placed in phantoms and patients.The japanese breast cancer society, 24, 585-592.Doi 10.1007/s12282-016-0741-0.Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: although the sample was not returned for evaluation, three images were provided for review.The image review demonstrated a high density linear pattern consistent with what appears to be an implanted tissue marker.However, the investigation is inconclusive for patient-device incompatibility as the image review could not confirm a reaction.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: indications for use: the ultraclip dual trigger breast tissue marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.Warnings: as with any foreign object implanted into the body, potential adverse reactions are possible.It is the responsibility of the physician to evaluate the risk/benefit prior to the use of this device.Potential complications: potential complications of marker placement may consist of hematoma, hemorrhage, infection, adjacent tissue injury and pain.The ultraclip dual trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (pva).

Event Description

It was reported in an article in the japanese breast cancer society titled "evaluation of the sonographic visibility and sonographic appearance of the breast biopsy marker (ultraclip) placed in phantoms and patients", following mastectomy, during pathologic examination, foreign body reaction was observed.The current patient status was not provided.

• Brand Name: ULTRACLIP DUAL TRIGGER BREAST TISSUE 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: 6917281
• MDR Text Key: 88838410
• Report Number: 2020394-2017-01275
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ULTRACLIP DT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• 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