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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number A35HPV07040080
Device Problem Material Puncture/Hole
Event Date 06/26/2019
Event Type  Malfunction  
Manufacturer Narrative

The fortrex balloon was returned. No ancillary devices were returned. The fortrex was inspected and the balloon showed signs of the previous inflation. The balloon was expanded. No damages or anomalies were observed. An inflation device filled with water was connected to the balloon inflation port after being loaded over a guidewire. The balloon was able to inflate to 12 atm; however, the balloon pressure could not be maintained. It was discovered a spray of water was coming out of a hole to the catheter shaft approximately 0. 2 cm distal the strain relief. Under microscope the hole was longitudinal, consistent with possible contact/penetration of a sharp instrument. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the physician intended to use a fortrex pta balloon to treat a fistula. There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop. The device was prepped without issue. The device did not pass through a previously deployed stent, no resistance was encountered nor excessive force used on advancing the device tothe target lesion. The device was inflated but, on first inflation and at 0atm, a leak was observed at the luer/hub. Another pta was use to complete the procedure. No patient injury was reported.

 
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Brand NameFORTREX 0.035 OTW PTA BALLOON CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway  
091708734
MDR Report Key9069021
Report Number2183870-2019-00450
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/16/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberA35HPV07040080
Device LOT NumberA789967
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/11/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/27/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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