MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CARBOFLO; EPTFE VASCULAR GRAFT

Catalog Number	F8006TWSC
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
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.D2b (dyf;dsy) 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 or Problem Description
On (b)(6) 2025, a patient underwent a surgical graft placement procedure using the carboflo.During the procedure the clinician was unable to remove the spiral beading from graft.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: received one sealed lot sample eptfe impra vascular graft for evaluation.Upon visual inspection, no anomalies were noted to the outer packaging.The device packaging was opened, and no anomalies were noted to any of the inner packaging material.The device was removed from the packaging, and no anomalies were noted to the device.The beading was noted to be correct based on the product information.During functional testing, a segment was cut off one end of the device.The ring of beading was grabbed by hand and was pulled off the device with no resistance.A segment was then cut off the opposite end of the graft, and the beading was also able to be removed by hand with no issue.The beading was then grabbed and started to be removed from the remaining full graft segment.No resistance was felt and the beading was being removed without issue.However, the actual complaint sample was not returned, the investigation is inconclusive for the reported separation failure.A definitive root cause for the reported separation failure 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.G3, h6 (device, component, method, result, conclusion).Section a through f: the information provide 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 a surgical graft placement procedure using the carboflo.During the procedure the clinician was unable to remove the spiral beading from graft.There was no reported patient injury.

• Brand Name: CARBOFLO
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23776878
• Report Number: 2020394-2025-02161
• Device Sequence Number: 10079773
• Product Code: DYF
• UDI-Device Identifier: 00801741021626
• UDI-Public: (01)00801741021626(17)290911(10)VTJW0235
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: F8006TWSC
• Device Lot Number: VTJW0235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown