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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD VACCESS ANGIOPLASTY BALLOON ANGIOPLASTY BALLOON/ CATHETER ANGIOPLASTY

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BARD VACCESS ANGIOPLASTY BALLOON ANGIOPLASTY BALLOON/ CATHETER ANGIOPLASTY Back to Search Results
Catalog Number VA80104
Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104); Fracture (1260); Difficult to Remove (1528)
Patient Problem No Code Available (3191)
Event Date 02/13/2018
Event Type  Injury  
Event Description
The 10 x 40 mm vaccess angioplasty balloon (bard incorporated) tore during 3rd inflation at 8 atm while treating three venous stenosis that had been previously stented. No inflation exceeded rated burst pressure of 15 atm. Balloon tore circumferentially, rather than longitudinally, so its central half could not be removed via 6 fr sheath, or via the access with sheath removed. Central half of balloon crumpled against fistula wall with traction on the catheter. Via two new accesses occlusive balloons were placed to isolated fractured balloon from blood stream and prevent emboliation. Initial access was enlarged and after it detached from catheter body, balloon fragment still attached to catheter tip was extracted with forceps. Surgical wound closed with dissolvable suture. Stenoses successfully treated angiographically. Fistula patent immediately following procedure.
 
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Brand NameVACCESS ANGIOPLASTY BALLOON
Type of DeviceANGIOPLASTY BALLOON/ CATHETER ANGIOPLASTY
Manufacturer (Section D)
BARD
tempe AZ 85281
MDR Report Key7276106
MDR Text Key100421242
Report NumberMW5075287
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/11/2021
Device Catalogue NumberVA80104
Device Lot Number93NC0034
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/15/2018 Patient Sequence Number: 1
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