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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VACCESS PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. VACCESS PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number VA8088
Device Problem Material Rupture (1546)
Patient Problem Extravasation (1842)
Event Date 06/14/2021
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot. Investigation summary: the physical device was not returned for evaluation. No photos were provided for review. Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review. A definitive root cause for the reported balloon rupture could not be determined based upon the provided information. Labeling review: a review of product labeling documentation (e. G. , procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy. Expiry date: 04/2024.
 
Event Description
It was reported that during the post-dilation of covera stent placement procedure, the vaccess balloon was burst and extravasation was observed. The covera stent was deployed successfully and the balloon was changed to conquest. The current patient status was not provided.
 
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Brand NameVACCESS
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
FUTUREMATRIX INTERVENTIONAL
1605 enterprise street
athens 75751
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12258372
MDR Text Key264468190
Report Number2020394-2021-01413
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVA8088
Device Catalogue NumberVA8088
Device Lot Number93RF0162
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/02/2021 Patient Sequence Number: 1
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