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

Catalog Number	DF5007SC
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical graft implantation procedure, the graft allegedly fell apart while trying to insert into the body.It was further reported that rings on the outside of the graft started uncoiling off the graft, therefore the middle piece of the graft was easily able to collapse.The procedure was complete using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d2b (dyf;dsy), d4 (expiry date: 10/2028).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.
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 received for evaluation.Upon visual evaluation, the sample was noted to have residue throughout.The graft measured approximately 50.7cm from end to end.The graft was cut in end one.Beading detachment was noted from 29.4cm until 33.5cm.Indentations were noted throughout the detached portion of the graft.Beading marks were noted throughout the center of the graft.No functional evaluation was performed due to the nature of the event.Therefore, the investigation is confirmed for the reported beading peeled issue as beading detachment was noted on the graft.A definitive root cause for the reported 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.H10: g3, h6 (method).H11: d2b (dyf, dsy), d4 (unique identifier (udi) #), h6 (result, conclusion).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
It was reported that during a surgical graft implantation procedure, the graft allegedly fell apart while trying to insert into the body.It was further reported that rings on the outside of the graft started uncoiling off the graft, therefore the middle piece of the graft was easily able to collapse.The procedure was complete using another device.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2024, a patient underwent a surgical graft implantation procedure using eptfe.It was reported that during a procedure, the graft allegedly fell apart while trying to insert into the body.It was further reported that rings on the outside of the graft started uncoiling off the graft, therefore the middle piece of the graft was easily able to collapse.The procedure was complete 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 received for evaluation.Upon visual evaluation, the sample was noted to have residue throughout.The graft measured approximately 50.7cm from end to end.The graft was cut in end one.Beading detachment was noted from 29.4cm until 33.5cm.Indentations were noted throughout the detached portion of the graft.Beading marks were noted throughout the center of the graft.No functional evaluation was performed due to the nature of the event.Therefore, the investigation is confirmed for the reported beading peeled issue as beading detachment was noted on the graft.A definitive root cause for the reported 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: 19927346
• Report Number: 2020394-2024-01179
• Device Sequence Number: 18177977
• Product Code: DSY
• UDI-Device Identifier: 00801741023514
• UDI-Public: (01)00801741023514(17)281017(10)VTHX0366
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K983861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,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 Catalogue Number: DF5007SC
• Device Lot Number: VTHX0366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 05/08/2026
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/30/2024; 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: Female
• Patient Weight: 59 KG