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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ATLAS PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number AT75204
Device Problems Material Frayed (1262); Material Rupture (1546); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for these events. The device was returned for evaluation. A visual inspection found frayed and unraveled fibers on the balloon. The device was inflated during functional testing and water was seen exiting from the balloon. The fibers were removed, and a longitudinal rupture was identified. Therefore, the investigation is confirmed for frayed and unraveled material, as well as a longitudinal rupture. The definitive root cause is unknown. The device is labeled for single use. The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
This report summarizes one malfunction event. A review of this event indicated that model at75204 pta balloon dilatation catheter experienced frayed material, longitudinal rupture, and unraveled material. This report was received from one source. One patient was involved with no patient consequences. The patient is a (b)(6)-year-old male. Patient weight was not provided.
 
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Brand NameATLAS 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)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8565143
MDR Text Key143587300
Report Number2020394-2019-00531
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 Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 04/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAT75204
Device Catalogue NumberAT75204
Device Lot NumberGFCP3945
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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