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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); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
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. Per the reported event details, the target lesion was calcified, and a wall stent was present during the procedure. Therefore, it is possible that patient and/or procedural issues contributed to the event. However, the definitive root cause for the identified compound rupture could not be determined based upon available information.
 
Event Description
This report summarizes one (1) malfunction. A review of the reported information indicated that model at75186 pta balloon dilatation catheter allegedly experienced material frayed, material rupture, and unraveled material. This information was received from one source. The malfunction involved a patient with no known impact to the patient. The (b)(6) year old female patient was (b)(6) lbs.
 
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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 Key8808485
MDR Text Key151640038
Report Number2020394-2019-01625
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
Device Model NumberAT75186
Device Catalogue NumberAT75186
Device Lot NumberGFCY2089
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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