Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DISTAFLO MINI-CUFF BYPASS GRAFT; EPTFE VASCULAR GRAFT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. DISTAFLO MINI-CUFF BYPASS GRAFT; EPTFE VASCULAR GRAFT Back to Search Results
Model Number DFX7006SC
Device Problem Obstruction of Flow (2423)
Patient Problems Thrombosis (2100); No Consequences Or Impact To Patient (2199)
Event Date 11/05/2018
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
 
Event Description
It was reported that approximately one month post bypass graft implantation in the sfa to the popliteal artery, the vascular graft was allegedly thrombosed with no blood flow to the foot.The patient underwent surgery to implant a second bypass graft.
 
Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The 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 not returned for evaluation.Therefore, the investigation is inconclusive for obstruction within device as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: 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.(expiry date 03/2022).
 
Event Description
It was reported that approximately one month post bypass graft implantation in the sfa to the popliteal artery, the vascular graft was allegedly thrombosed with no blood flow to the foot.The patient underwent surgery to implant a second bypass graft.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DISTAFLO MINI-CUFF BYPASS GRAFT
Type of Device
EPTFE VASCULAR GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key8124287
MDR Text Key129035019
Report Number2020394-2018-02144
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00801741023668
UDI-Public(01)00801741023668
Combination Product (y/n)N
PMA/PMN Number
K983769
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDFX7006SC
Device Catalogue NumberDFX7006SC
Device Lot NumberVTBQ0012
Was Device Available for Evaluation? No
Date Manufacturer Received05/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-