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

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

  • 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
 

COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number A35HPV08040080
Device Problem Burst Container or Vessel (1074)
Patient Problems Embolism (1829); Device Embedded In Tissue or Plaque (3165)
Event Date 08/31/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a fortrex pta balloon during procedure to treat a lesion in left distal of an unknown vessel with 75%. The vessel diameter and lesion length are 8mm and 40mm respectively. The vessel was little tortuous. There was no damage to device packaging. There was no issue removing device from hoop/tray. The device was prepped per ifu with no issues identified. The device did not pass through a previously-deployed stent. There was no resistance encountered when advancing the device. Excessive force was not used. It was reported that during first balloon inflation, circumferential/radial burst at 20 atm occurred. All fragments of the balloon was not retrieved. Perm cath was implanted after patient dialysis graft shut down. Dialysis graft shut down with a portion of the fortrex remaining inside the patient. Perm cath was implanted as a result. No further patient injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10520316
MDR Text Key206506221
Report Number2183870-2020-00291
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,Followup,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA35HPV08040080
Device Catalogue NumberA35HPV08040080
Device Lot NumberB054194
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2020
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: 09/11/2020 Patient Sequence Number: 1
-
-