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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 VA8094
Device Problem Deflation Problem (1149)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/08/2021
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. 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 deflation issue 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: 06/2024). Device not returned.
 
Event Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had deflation problem. It was further reported that the balloon allegedly got stuck in the sheath and a blade was used to cut the access site to remove balloon and sheath. The current status of the patient is unknown.
 
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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 Key12947977
MDR Text Key281836009
Report Number2020394-2021-02039
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 Other,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVA8094
Device Catalogue NumberVA8094
Device Lot Number93TF0065
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2021
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: 12/07/2021 Patient Sequence Number: 1
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