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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
Model Number A35HPV08040080
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 02/12/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During index procedure, a medtronic pta balloon was used to treat the venous outflow in the left arm. Approximately 23 months post procedure, patient suffered stenosis in the avf which was treated using a non-medtronic pta balloon. Patient recovered. Investigator and sponsor assessed event is not related to device, procedure or paclitaxel.
 
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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 Key9858976
MDR Text Key190926363
Report Number2183870-2020-00089
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/19/2020
Device Model NumberA35HPV08040080
Device Catalogue NumberA35HPV08040080
Device Lot NumberA542693
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/20/2020 Patient Sequence Number: 1
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