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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. IMPRA CARBOFLO EPTFE VASCULAR GRAFT Back to Search Results
Model Number F7007TWSC
Device Problem Torn Material (3024)
Patient Problem No Patient Involvement (2645)
Event Date 05/24/2017
Event Type  malfunction  
Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.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.The information provided by bard 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 bard.
 
Event Description
It was reported that during a demonstration for removal of beading on a surgical graft, the graft tore.There was no patient involvement.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.The beading was found to be removed from a large portion of the returned graft.In the area in which the beading was removed the graft was spirally torn.Therefore, the investigation can be confirmed for the alleged torn material.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current instructions for use (ifu) states: precautions: when removing the external spiral support (beading) of the graft, the beading must be removed slowly and at a 90° angle to the graft.Rapid unwinding and /or removal at less than a 90° angle may result in graft damage.Do not use surgical blades or sharp, pointed instruments to remove the beading as this may damage the graft wall.If damage occurs, that segment of the graft should not be used.
 
Event Description
It was reported that during a demonstration for removal of beading on a surgical graft, the graft tore.There was no patient involvement.
 
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Brand Name
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
Type of Device
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
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key6654400
MDR Text Key78022550
Report Number2020394-2017-00674
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00801741021602
UDI-Public(01)00801741021602(17)210109(10)VTAN0212
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K004011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/14/2017
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
Device Operator Other
Device Expiration Date01/09/2021
Device Model NumberF7007TWSC
Device Catalogue NumberF7007TWSC
Device Lot NumberVTAN0212
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/24/2017
Initial Date FDA Received06/20/2017
Supplement Dates Manufacturer Received09/12/2017
Supplement Dates FDA Received09/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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