MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR FIRE FORWARD; BIOPSY INSTRUMENT

Model Number ENCFF02

Device Problems Contamination (1120); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2022

Event Type  malfunction  

Event Description

It was reported that during biopsy procedure, the threads on the fire forward are stripped and it will no longer screw onto the hologic affirm stereotactic system.This issue has resulted in failed vacuum biopsy on a patient a few weeks earlier where the device fell off the affirm machine during the firing of the vacuum needle, and had to forfeit the procedure due to danger to the patient.There was no reported patient injury.

Manufacturer Narrative

As the serial number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiration date: 12/2040).

Manufacturer Narrative

H10: manufacturing review: a device history record and manufacturing review was not required as the event was determined to be expected and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the physical sample of encor fire forward was received for evaluation.The encor fire forward was visually inspected upon receipt and was found to be in good overall condition and functions normally and the cover was scratched, upon disassembly, it was found that the device was contaminated with blood.The device was functionally tested and passed the tests during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported unintended movement issue and the investigation is determined to be confirmed for the identified contamination issue.One photo of encor fire forward and two photos of hologic affirm stereotactic system were provided for review.In the first photo ¿20221223_163642.Jpg¿, the fire forward's center screw thread was shown.In the second photo ¿20221223_164121.Jpg¿, screw with the hologic affirm stereotactic system was shown in partial view.In the third photo ¿693892546.Jpg¿, shows labeling information of hologic affirm stereotactic system.No visual anomalies were noted of the internal component.One video of encor fire forward was also provided for review.In the video "20221223_163813_001.Mp4", user trying to fit the fire forward with hologic affirm stereotactic system but was unable to screw together.No visual anomalies were noted of the internal component.Therefore based on the photo and video review, the investigation is determined to be inconclusive for the reported unintended movement and a definitive root cause for the reported unintended movement could not be determined based upon the provided information.Hence, based on the evaluation, the root cause for the reported unintended movement issue cannot be determined as the problem could not be reproduced.The root cause for the identified contamination issue is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 12/2040).H11: section a through f - the information provided by bd 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 bd.

Event Description

It was reported that during biopsy procedure, the threads on the fire forward are stripped and it will no longer screw onto the hologic affirm stereotactic system.This issue has resulted in failed vacuum biopsy on a patient a few weeks earlier where the device fell off the affirm machine during the firing of the vacuum needle, and had to forfeit the procedure due to danger to the patient.There was no reported patient injury.

• Brand Name: ENCOR FIRE FORWARD
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16231799
• MDR Text Key: 309155534
• Report Number: 2020394-2022-01084
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086458
• UDI-Public: (01)00801741086458
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENCFF02
• Device Catalogue Number: ENCFF02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1