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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 AT75166
Medical Device Problem Codes Material Frayed (1262); Material Rupture (1546); Unraveled Material (1664)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number was provided for the malfunction and a lot history review was performed.The device was returned for evaluation and investigation is confirmed for reported unraveled balloon material, frayed fiber, fiber disturbance, balloon rupture and peeled coating.A definitive root cause could not be determined.The device is labeled for single use.(b)(4).
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model at75166 pta dilatation catheter allegedly experienced balloon rupture, frayed fibers, peeled coating, fiber disturbance and unraveled balloon.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
 
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Brand Name
ATLAS PTA DILATATION CATHETER
Common Device Name
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10299763
Report Number2020394-2020-04693
Device Sequence Number18950193
Product Code DQY
UDI-Device Identifier00801741062476
UDI-Public(01)00801741062476
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberAT75166
Device Catalogue NumberAT75166
Device Lot NumberGFDZ2379
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/20/2020
Patient Sequence Number1
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