• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. ATLAS PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number AT75124
Device Problems Material Frayed; Inflation Problem; Peeled / Delaminated
Event Type  Malfunction  
Manufacturer Narrative

The lot number was provided and a lot history review was performed. The sample was returned and the investigation confirmed for frayed fibers, peeling pebax, unraveled fibers, and uneven inflation. The definitive root cause could not be established. The device is labeled for single use. (b)(4).

 
Event Description

This report summarizes one malfunction. A review of the reported information indicated that model at75124 pta balloon dilatation catheter allegedly experienced material frayed, inflation issues, peeled layer, and unraveled material. This information was received from one source. One patient was involved and there was no reported patient injury. Patient information was not provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9194970
Report Number2020394-2019-03971
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 10/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberAT75124
Device Catalogue NumberAT75124
Device LOT NumberGFDQ0435
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 Received09/30/2019
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

-
-