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

Model Number	F7006TWSC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have not been returned for evaluation; therefore, the investigation is inconclusive for the material being split, cut or torn as no objective evidence has been provided to confirm any alleged deficiency with the eptfe vascular graft.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model f7006twsc eptfe vascular grafts allegedly experienced material being split, cut or torn.This report was received from various sources.Of the two alleged incidences of material being split, cut or torn, neither involved patients as there was no patient contact.The patients ages and weights were not provided.

• Brand Name: CARBOFLO VASCULAR GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8783029
• Report Number: 2020394-2019-01468
• Device Sequence Number: 19492668
• Product Code: DSY
• UDI-Device Identifier: 00801741021596
• UDI-Public: (01)00801741021596
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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: No Information
• Device Model Number: F7006TWSC
• Device Catalogue Number: F7006TWSC
• Device Lot Number: VTCS0068, VTCW0003
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/11/2019
• Patient Sequence Number: 1