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

Catalog Number 862017D

Device Problems Poor Quality Image (1408); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 06/23/2016

Event Type  Injury  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.A lot sample has 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 following a stereotactic guided breast tissue maker placement procedure, it was allegedly not possible to see the marker under ultrasound.Reportedly, the health care provider (hcp) performed seven attempts over a span of six to eight months to locate the marker under ultrasound without success.Each time during the six to eight months of follow ups, the marker was visible under mammography where the patient was reportedly evolving well to chemotherapy.It was further reported that at around six to eight months post deployment, the facility¿s mammography equipment was out of order and the marker was unable to be visualized under both mammography and ultrasound.Allegedly, the hcp was unable to demonstrate the evolution of the lesion with respect to the marker and a mastectomy was performed.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Visual/microscopic inspection: a lot sample was returned for evaluation.The sample was clean.The marker system was returned in a deployed configuration as the pusher was exposed and the trigger was in the fired position.The marker with attached pva was returned separate from the marker system.No anomalies were noted on marker system or the marker.Functional/performance evaluation: functional testing could not be performed, as the marker systems had been deployed.The lot sample was evaluated under x-ray.The marker was able to be visualized without issue.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images were provided.Based on the images provided, due to the image quality a breast tissue maker could not be identified in the ultrasound images, can be confirmed.Based on the images provided, due to the image quality a breast tissue maker could not be identified in the mammograms provided, can be confirmed.Conclusion: one ultraclip dual trigger lot sample was returned for evaluation and images were provided for review; however, medical records were not provided for review.The investigation is inconclusive, as the original sample was not returned.The returned lot sample could not be functionally tested as it was returned in the deployed configuration; however, the marker was able to be visualized under x-ray.Additionally, the investigation could not be confirmed based on the images provided, as the poor quality of the images prevented a proper assessment.Therefore, the overall investigation is inconclusive.Per the reported event details it was noted that the marker was able to be visualized several times under mammography; however, the user was unable to view the marker under ultrasound.It is unknown if patient, procedural, or imaging techniques contributed to the reported event.Therefore, based upon the available information, the definitive root cause could not be determined.Labeling review: the current ultraclip dual trigger instructions for use (ifu) states: general information and device description: 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 six to eight months post breast tissue maker placement, the health care provider (hcp) was unable to demonstrate the evolution of the lesion in relation to the marker placement.It was further reported that as the progression of the cancer could not clearly be identified the hcp performed a mastectomy for the end treatment.

• Brand Name: ULTRACLIP DUAL TRIGGER BREAST TISSUE 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; 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: 6402850
• MDR Text Key: 69894047
• Report Number: 2020394-2017-00182
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032219
• UDI-Public: (01)00801741032219(17)190128(10)HUAP1512
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K090547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Catalogue Number: 862017D
• Device Lot Number: HUAP1512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2016
• 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): Disability
• Patient Age: 36 YR
• Patient Weight: 63