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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CARBOFLO VASCULAR GRAFT; EPTFE VASCULAR GRAFT
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BARD PERIPHERAL VASCULAR, INC. CARBOFLO VASCULAR GRAFT; EPTFE VASCULAR GRAFT Back to Search Results
Model Number 40A64C
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2018
Event Type  Injury  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.A photo was provided.The lot number for the device was provided.The device history records and photo are currently under review.The return of the device is pending.The investigation is currently under way.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 an angiography approximately 50 days post procedure, the inner lumen surface of the vascular graft was allegedly not smooth and something tattered was found.It was further reported that the health care provider (hcp) punctured the graft and allegedly retrieved a film-like substance.Reportedly, a second procedure was performed to remove and replace the vascular graft with another.Upon completion of the second procedure, the hcp recanted the allegation of foreign material as it did not originate from the graft.The patient was reported as recovering through dialysis with hd catheter post second procedure.
 
Event Description
It was reported that during an angiography approximately 50 days post procedure, the inner lumen surface of the vascular graft was allegedly not smooth and something tattered was found.It was further reported that the health care provider (hcp) punctured the graft and allegedly retrieved a film-like substance.Reportedly, a second procedure was performed to remove and replace the vascular graft with another.Upon completion of the second procedure, the hcp recanted the allegation of foreign material as it did not originate from the graft.The patient was reported as recovering through dialysis with hd catheter post second procedure.
 
Manufacturer Narrative
A manufacturing review was not performed as the lot number was not provided.The device was not returned for evaluation.Medical records were not provided for review.One photo was provided and reviewed.The photo shows a film like substance laid out on a paper towel.However, it is unknown what the substance is.Therefore, the investigation is inconclusive for foreign material.Per the event details, the foreign material was not from the vascular graft.The alleged film like substance is most likely from a clot or tissue growth.However, the definitive root cause is unknown.A review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
 
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Brand Name
CARBOFLO VASCULAR GRAFT
Type of Device
EPTFE VASCULAR GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7787478
MDR Text Key117256362
Report Number2020394-2018-01476
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00801741020995
UDI-Public(01)00801741020995
Combination Product (y/n)N
PMA/PMN Number
K004011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number40A64C
Device Catalogue Number40A64C
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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