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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 A35HPV12080080
Device Problem Burst Container or Vessel (1074)
Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Date 12/01/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: month and year valid. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a fistulogram, a fortrex device burst. The patient had a venotomy to remove the fragments of balloon but this was unsuccessful. The patient was admitted to hospital and taken for a repeat fistulogram the next day. The fragments from the fortrex balloon were in the subclavian vein near the proximal stent. A stent was used to cage the fragments to the patient's vessel wall.
 
Manufacturer Narrative
Additional information: burst occurred during balloon inflation in the great saphenous vein (gsv). If information is provided in the future, a supplemental report will be issued.
 
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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 Key8339230
MDR Text Key136144296
Report Number2183870-2019-00073
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/24/2021
Device Catalogue NumberA35HPV12080080
Device Lot NumberA744172
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 Received02/22/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/25/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/14/2019 Patient Sequence Number: 1
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