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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 AT75144
Device Problems Material Frayed (1262); Material Rupture (1546); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the device was provided, therefore a lot history review was performed. The device was returned and is confirmed for fiber disturbance and catheter shaft tears. The investigation is inconclusive for rupture. The definitive root cause is unknown. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the information indicates that model at75144 experienced frayed material, rupture, and split material. The information was received from one source. The malfunction involved a patient with no reported patient injury. The patient's age, weight, and gender were 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
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9588956
MDR Text Key180119635
Report Number2020394-2020-00261
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 01/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/14/2020
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 NumberGFDU2287
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 Received12/31/2019
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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