MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DT BREAST TISSUE MARKER; BREAST LOCALIZATION WIRE

Catalog Number 864017D

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be performed, as the lot number was 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/photo review: no medical images were made available to the manufacturer.Conclusion: the investigation is inconclusive, as the samples were not returned for evaluation and images were not provided for review.Per the reported event details, the biopsy clip was visualized under mri imaging.The current ifu (instructions for use) 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.

Event Description

It was reported that post tissue marker placement under mri imaging, there allegedly was a blooming artifact.There was no reported patient injury.

• Brand Name: ULTRACLIP DT BREAST TISSUE MARKER
• Type of Device: BREAST LOCALIZATION WIRE
• 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: 6198723
• MDR Text Key: 63194543
• Report Number: 2020394-2016-01194
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032257
• UDI-Public: (01)00801741032257
• 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: Other
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 864017D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1