MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GELMARK ULTRA; BREAST TISSUE MARKER

Catalog Number GMUEC10GSS

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and the reported lot met all release criteria.Visual inspection:the sample was not returned; therefore, visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the definitive root cause for the reported issues could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review: the current gel mark ultra breast biopsy marker instructions for use (ifu) states: precautions: - the device should only be used by physicians trained in the percutaneous biopsy procedures.Do not use this product if the sterile barrier has been previously opened or if the package is damaged.Do not kink the flexible tube.Complications: - potential complications that may be associated with the use of the gel mark ultra biopsy site marker are similar to those associated with the use of other biopsy marking devices.Directions for use: using standard aseptic technique, remove the device from the package.Remove tip cover.Caution: if resistance is felt while removing the applicator, remove the entire probe/applicator assembly from the patient.Failure to do so may result in breakage of the applicator tip.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 stereotactic breast biopsy, the marker applicator was allegedly difficult to insert within the probe and difficult to remove from the probe.The probe and applicator were removed together with the probe aperture closed.The probe aperture was opened and the marker applicator tip was detached.There was no reported patient injury.

Manufacturer Narrative

Visual inspection: the marker was returned with the plunger fully depressed.No pellets remained within the applicator.No pellets were returned deployed from the marker.The wireform was not returned for evaluation.The tip of the applicator was found to be cut approximately 2cm from the distal tip.The cut portion of the distal tip was not returned.There also appeared to be stretching at the location of the break, indicating difficulty removing the applicator from the probe.Functional/performance evaluation: due to the condition of the returned applicator functional testing with the returned probe could not be performed.Conclusion: the investigation is confirmed for the reported detachment as the distal tip was found to be cut from the tip of the applicator.The investigation is also confirmed for the removal difficulties due to the stretching and damage to the tip.The investigation is inconclusive for the inserting issue, due to the returned sample condition.Per the reported event details, after the health care professional removed the applicator from the patient, the foot pedal was pressed which could have cut the distal tip from the applicator.However the definitive root cause for the reported insertion or removal difficulties could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.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: GELMARK ULTRA
• Type of Device: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5525058
• MDR Text Key: 41122053
• Report Number: 2020394-2016-00296
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K011402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: GMUEC10GSS
• Device Lot Number: VT14H0282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2014
• 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