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

Model Number	DFM6006SC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that sometime post graft placement, pseudoaneurysm was formed in a graft rather than the anastomotic site.The patient current status is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review, device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one distaflo graft in two segments pinned to an unknown specimen board was returned for evaluation.Gross visual evaluation was performed.The large graft segment measures approximately 3.5cm, partial beading noted on both ends, both edges of the graft are uneven, and jagged edges.Rust was noted on two of the holes.Small graft segment measures approximately 1.5cm and has uneven and jagged edges.No other anomalies were noted.The investigation is inconclusive for the reported pseudoaneurysm, as the exact circumstances at the time of the reported event are unknown.The definitive root cause for the reported pseudoaneurysm could not be determined based upon available information.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: g4.H11: h6(result, conclusion).H11: 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
It was reported that sometime post graft placement, the graft allegedly had pseudoaneurysm.The patient current status is unknown.

• 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
• MDR Report Key: 10903695
• Report Number: 2020394-2020-20610
• Device Sequence Number: 1335621
• Product Code: DSY
• UDI-Device Identifier: 00801741023637
• UDI-Public: (01)00801741023637
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DFM6006SC
• Device Catalogue Number: DFM6006SC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other