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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, TRANSLUMINA

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COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Catalog Number A35HPV06080080
Device Problems Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2021
Event Type  malfunction  
Event Description
Physician was attempting to use fortrex pta balloon catheter during procedure to treat a plaque lesion in the left mid radial bone cephalic vein. The vessel was severely tortuous. The vessel diameter and lesion length are 6m and 8mm respectively. No embolic protection was used. A syringe was used for balloon inflation. There was no issue noted when removing device from hoop/tray. The device was prepped per ifu with no issue identified. The vessel was stenosed. The catheter/delivery system was deformed with a kink on the shaft noted. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. It is reported that the event occurred during the shunt percutaneous transluminal angioplasty (pta). After passing the wire through, when the device was passed through the lesion, the shaft of the balloon portion broke in several places and the device could not be advanced. The balloon was replaced with another product and inflation was performed to complete the procedure. There was no patient injury reported.
 
Manufacturer Narrative
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, TRANSLUMINA
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 
EI  
091708734
MDR Report Key12869124
MDR Text Key283112282
Report Number2183870-2021-00425
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K142654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA35HPV06080080
Device Lot NumberB079234
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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