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

Catalog Number	DFM6006SC
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical graft placement procedure in the femoral-popliteal artery lesion, the graft allegedly tore during suturing of the central anastomosis and became unusable.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
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.(expiration date: 12/2024).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
It was reported that during a surgical graft placement procedure in the femoral-popliteal artery lesion, the graft allegedly tore during suturing of the central anastomosis and became unusable.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one distaflo graft in multiple segments received for evaluation.Upon visual evaluation, the samples were noted to have residue throughout.Segment one measured approximately 27.1cm from end to end.Beading was noted to be detached at the distal end of segment one.Indentations were noted throughout the distal portion of the graft; area where the beading was detached.Segment two measured approximately 35.2cm from end to end.A tear was noted at end one; detached beading was noted in area.One bead was also noted to be detached from the graft, proximal to the flair end of the graft.A tear was noted on the edge of the flair end of the graft.Additionally, three small segments were returned separately.No functional evaluation was performed due to the nature of the event.Therefore, the investigation is confirmed for the reported torn material issue as tear was noted on the graft and the investigation is also confirmed for the identified beading peeled issue as beading detachment was noted on the graft.A definitive root cause for the reported torn issue and identified beading peeled issue 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.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 or Problem Description
On (b)(6) 2024, a patient underwent a surgical graft placement procedure in the femoral popliteal artery lesion.During the procedure, it was reported that the graft allegedly tore during suturing of the central anastomosis and became unusable.The procedure was completed using another device.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: one distaflo graft in multiple segments received for evaluation.Upon visual evaluation, the samples were noted to have residue throughout.Segment one measured approximately 27.1cm from end to end.Beading was noted to be detached at the distal end of segment one.Indentations were noted throughout the distal portion of the graft area where the beading was detached.Segment two measured approximately 35.2cm from end to end.A tear was noted at end one; detached beading was noted in area.One bead was also noted to be detached from the graft, proximal to the flair end of the graft.A tear was noted on the edge of the flair end of the graft.Additionally, three small segments were returned separately.No functional evaluation was performed due to the nature of the event.Therefore, the investigation is confirmed for the reported torn material issue as tear was noted on the graft and the investigation is also confirmed for the identified beading peeled issue as beading detachment was noted on the graft.A definitive root cause for the reported torn issue and identified beading peeled issue 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.B5, g2, g3, h6 (component).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.

• Brand Name: DISTAFLO BYPASS GRAFT
• 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: 19834568
• Report Number: 2020394-2024-01107
• Device Sequence Number: 17804415
• Product Code: DSY
• UDI-Device Identifier: 00801741023637
• UDI-Public: (01)00801741023637(17)241209(10)VTDZ0226
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2026

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 Expiration Date: 12/09/2024
• Device Catalogue Number: DFM6006SC
• Device Lot Number: VTDZ0226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 05/08/2026
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 10/23/2024; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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