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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) ATLAS PTA BALLOON DILATATION CATHETER

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C.R. BARD, INC. (GFO) ATLAS PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number AT75144
Device Problems Material Frayed; Peeled / Delaminated
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. This is the only complaint reported to date for this lot number and failure mode. The device was returned for evaluation. A visual inspection found frayed fibers in the balloon barrel and distal cone. Fiber disturbance and slight peeling of the outer pebax layer were also found in the balloon barrel. Therefore, the investigation is confirmed for frayed fibers and peeled pebax. Per the reported event details, the device was inflated inside a stent during the procedure. Therefore, it is possible that the interaction between the stent and the balloon contributed to the reported issues. However, the definitive root cause for the reported issues could not be determined based upon the available information. The device is labeled for single use.

 
Event Description

This report summarizes one (1) malfunction event. A review of the events indicated that model at75144 pta balloon dilatation catheter during pre-dilatation of a stent in the right brachiocephalic vein, allegedly experienced frayed material and a peeled outer layer, upon removal from the patient. The procedure was completed with another device. This report was received from one source. This event involved one male patient, (b)(6) and approximately (b)(6). This patient had no reported patient injury.

 
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Brand NameATLAS PTA BALLOON DILATATION CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
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 Key8523916
Report Number2020394-2019-00414
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 04/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberAT75144
Device Catalogue NumberAT75144
Device LOT NumberGFCY1597
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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