• 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 AT75186
Device Problems Material Frayed (1262); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review will be performed. The device was returned for evaluation. A visual inspection was performed and frayed fibers were noticed on the balloon. No other anomalies were noted to the device. The balloon was attempted to be inflated, but it was unable to be due to dried blood in the sheath. Therefore, the investigation is confirmed for the identified frayed fibers, as fraying fibers were found on the balloon. The balloon rupture investigation is inconclusive, as the device was unable to be tested. Based upon the available information, the definitive root cause is unknown. The devices are labeled for single use.

 
Event Description

This report summarizes two (2) malfunction. A review of the reported information indicated that model at75186 pta balloon dilatation catheter allegedly experienced material frayed and a material rupture. This information was received from one source. The malfunctions involved one patient with no known impact to the patient. The (b)(6) year old female patient was (b)(6).

 
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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8824117
MDR Text Key152193324
Report Number2020394-2019-01829
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 07/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberAT75186
Device Catalogue NumberAT75186
Device LOT NumberGFCY2820
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

-
-