MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TREK POWER DRIVER; BIOPSY INSTRUMENT

Catalog Number	TKDRIVER
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent biopsy procedure using through the trek power driver.During the procedure, it was found that the driver was pausing periodically during cases.Further it was reported that the driver allegedly failed to stop when the trigger was released.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot 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.Section a through f ¿ the information provided by bd represents all 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: received one trek power driver within its original packaging.On visual evaluation, the trek power driver appeared to be clean.No other anomalies were observed.On functional testing, the trigger was pulled, the led was green, shows the variable speed intensity and the variable speed was functioning properly, and no unusual noises were heard.The hex head does not spin out of round.The device functions as intended.The device stopped immediately after releasing the trigger.The driver was loaded onto the digital tachometer, and the highest rpm was measured to be 439.3.Per ok tm 027 document, this measurement is within the acceptable range.Therefore, the investigation is unconfirmed for the reported mechanical jam as the device stopped immediately after releasing the triggered, functions as intended and the rpm measurement is within the acceptable range.A definitive root cause for the mechanical jam could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g3, h6 (device, method, result, conclusion).Section a through f: the information provided by bd represents all 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 or Problem Description
On (b)(6) 2025, a patient underwent biopsy procedure using through the trek power driver.During the procedure, it was found that the driver was pausing periodically during cases.Further it was reported that the driver allegedly failed to stop when the trigger was released.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: TREK POWER DRIVER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CAREFUSION MANNFORD; 400 foster rd; mannford OK 74044
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23955394
• Report Number: 2020394-2025-02319
• Device Sequence Number: 9447973
• Product Code: KNW
• UDI-Device Identifier: 00801741201356
• UDI-Public: (01)00801741201356(11)250618(17)300628(10)0001624069
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K213896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TKDRIVER
• Device Lot Number: 0001624069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown