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

Catalog Number 864017D

Device Problem Signal Artifact/Noise (1036)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

No hospital/medical records have been made available to the manufacturer.Images of the device were received.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 that post breast tissue marker placement under mri imaging there allegedly was a blooming artifact covering a carcinoma.It was further reported that the obscured view of the carcinoma allegedly prohibited the physician from determining further care for the patient.The patient is reportedly doing well.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be performed, as the lot number is 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 review: based on the images provided, no tissue markers could be identified in the images received, can be confirmed.Based on the images provided, a blooming artifact was demonstrated on every image received, can be confirmed.Conclusion: based on the images reviewed, the investigation is confirmed for the reported issue, as artifacts were identified in the mri images provided.Per the reported event details, the biopsy clip was visualized under mri imaging.The current ifu states, "mr image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the ultraclip dual trigger breast tissue marker.Therefore, it may be necessary to optimize mr imaging parameters for the presence of this metallic implant." it is possible that procedural issues and/or imaging techniques contributed to the reported event.However, based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: 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).The tissue marker, located inside the distal end of the introducer needle, is made of titanium, inconel 625 or biodur 108 and contains a pva polymer pellet interwoven with the marker to enhance viewing of the marker under ultrasound.Please note this polymer is non-absorbable.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.Mr conditional information: non-clinical testing has demonstrated that the tissue marker is mr conditional.It can be scanned safely under the following conditions: static magnetic field of 3-tesla or less.Spatial gradient filed of 720-gauss/cm or less.Maximum mr system reported whole-body-averaged specific absorption rate (sar) of 3-w/kg for 15 minutes of scanning.Mr image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the ultraclip® dual trigger breast tissue marker.Therefore, it may be necessary to optimize mr imaging parameters for the presence of this metallic implant.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: ULTRACLIP 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: 5486310
• MDR Text Key: 39887871
• Report Number: 2020394-2016-00245
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090547
• 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,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 864017D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2016
• 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
• Patient Outcome(s): Other