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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. VACCESS PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number VA8094
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
Event Description
It was reported that during an angioplasty procedure, the balloon was allegedly ruptured and detached and a piece of it was left in the stent. It was further reported that it was not able to be retrieved hence another stent was placed over it. There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported was unknown. Investigation summary: one (b)(6) catheter has been returned for evaluation. Balloon had a circumferential rupture exposing the inner guide wire lumen. The distal end of the balloon was noted to be detached and not returned. Both the marker bands are present. No other specific anomalies were noted on the returned device. All the anomalies were observed under microscopic observation. No functional testing was performed due to condition of the device. Therefore, the investigation for the reported balloon rupture was confirmed as the balloon had a circumferential rupture exposing the inner guide wire lumen. The investigation was also confirmed for the balloon detachment as the distal end of the balloon and catheter was noted to be detached and not returned for evaluation. A definitive root cause for the reported balloon rupture and balloon detachment 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.
 
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Brand NameVACCESS PTA DILATATION CATHETER
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 Key13540528
MDR Text Key285668461
Report Number2020394-2022-00105
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 02/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVA8094
Device Catalogue NumberVA8094
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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