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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vascular Dissection (3160); Restenosis (4576)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
Journal title: comparison of minimally invasive thrombectomy with percutaneous balloon angioplasty for organized thrombi in hemodialysis access jun-ted chong,1 ping-yen liu,2 mu-shiang huang2 and wei-da lu2 acta cardiol sin 2020;36:603610 doi: 10. 6515/acs. 202011_36(6). 20200621ba. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was submitted detailing a prospective study which aimed to investigate the safety and patency rate following minimally invasive thrombectomy (mit) as a rescue procedure for traditional pta with organized thrombi obstructing hemodialysis access. 4-7 mm medtronic pta balloons were used during procedures inflated to pressures of 12-14atm. 425 patients met the inclusion criteria of which 425 were treated by pta. Pta failure requiring mit bailout therapy performed simultaneously is reported in 46 cases. Pta success reported in the remaining 379 patients. Patient¿s were followed up at 7, 30, 60, 120, and 180 days following the procedure to assess patency of av access and complications such as bleeding or infection. Re-intervention and vascular access dysfunction were determined based on total occlusion, hardened aneurysm, decreased or absent thrill, increased pulsation, limb swelling, difficulty in cannulation, prolonged bleeding after hemodialysis, high venous pressure during hemodialysis, or presence of a suction phenomenon at the arterial site. All patients in the mit group achieved clinical success. Two patients in the mit group received mit following pta due to residual stenosis. There were no complications, including vessel perforation requiring surgery, hospital admission, unplanned increase in the level of care, permanent adverse sequelae, or death. A few venous dissections were encountered, but all were resolved with prolonged balloon inflation. There were no arterial embolism events following mit. Primary patency rates in the overall population reported as 7 days (97. 12%), 30 days (93. 20%), 60 days (86. 06%), 120 days (74. 26%), 180 days (69. 67%). Secondary patency rates in the overall population reported as 7 days (97. 6%), 30 days (95. 63%), 60 days (93. 89%), 120 days (92. 82%), 180 days (92. 48%).
 
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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 Key12187854
MDR Text Key262167134
Report Number2183870-2021-00243
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K142654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 07/19/2021 Patient Sequence Number: 1
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