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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 AT75186
Device Problems Material Frayed (1262); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The devices were both returned for evaluation. A visual inspection found frayed fibers on the balloons. The devices were inflated during functional testing and water was seen exiting from the balloons. The fibers were removed, and a longitudinal rupture was identified on the first device; pinhole rupture was identified on the second. Therefore, the investigation is confirmed for frayed material, as well as a longitudinal rupture. Per the reported event details, a wall stent was present during the procedures. Therefore, it is possible that patient and/or procedural issues contributed to the alleged malfunctions. However, the definitive root cause for the identified frayed material and longitudinal rupture could not be determined based upon available information.

 
Event Description

This report summarizes two malfunctions. A review of the reported information indicated that material on model at75186 atlas pta dilatation catheters allegedly frayed and ruptured. This information was received from various sources. The alleged malfunctions each involved a patient with no known impact to the patient. Both patients were reported to be female, one patient was reported to be (b)(6)-years-old and weigh (b)(6)lb; the other was reported to be (b)(6) -years-old and weigh (b)(6) lb.

 
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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 Key8809601
MDR Text Key151740508
Report Number2020394-2019-01640
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 07/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/19/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberAT75186
Device Catalogue NumberAT75186
Device LOT NumberGFCZ1773, GFCY2820
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 Received06/30/2019
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 Initial

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