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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L GORE AND ACCESSORIES, INC. GORE VIABAHN; DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT, SYSTEM ENDOVASCULAR GRAFT ARTERIOVEN
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W.L GORE AND ACCESSORIES, INC. GORE VIABAHN; DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT, SYSTEM ENDOVASCULAR GRAFT ARTERIOVEN Back to Search Results
Catalog Number VBCR070202A
Device Problems Fracture (1260); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2018
Event Type  Injury  
Event Description
An (b)(6) presented for fistulogram, thrombectomy and angioplasty w/stent graft deployment of a left arm hemodialysis graft.After the arterial plug and residual thrombus were removed, there was still a residual stenosis across the venous anastomosis, so a stent was deployed at the anastomosis.Upon removal of the transvenous catheter sheath, it was noticed that the distal end of the catheter was missing.On fluoroscopy the fractured tip of the venous catheter was still across the tip of the guidewire.The fractured tip was able to be retrieved intact.The catheter used was an 8 fr 7mm x 2.5 cm with 0.0325" guidewire compatibility.
 
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Brand Name
GORE VIABAHN
Type of Device
DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT, SYSTEM ENDOVASCULAR GRAFT ARTERIOVEN
Manufacturer (Section D)
W.L GORE AND ACCESSORIES, INC.
MDR Report Key8046238
MDR Text Key126644876
Report NumberMW5081123
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/25/2020
Device Catalogue NumberVBCR070202A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
Patient Weight64
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