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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
Device Problem Burst Container or Vessel (1074)
Patient Problems Hematoma (1884); Vascular Dissection (3160); Swelling/ Edema (4577)
Event Date 12/31/2019
Event Type  Injury  
Manufacturer Narrative

Title: rupture, breakdown, and pulmonary artery embolism of a balloon catheter tip during percutaneous transluminal angioplasty of arteriovenous fistula journal: vascular specialist international authors: young min han, kun yung kim, byeoung hoon chung year: 2019 vol <(>&<)> issue: 35(4) ref: doi: 10. 5758/vsi. 2019. 35. 4. 245. Average age, majority gender, of publication. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A journal article was submitted detailing a patient case report. Medtronic¿s fortrex balloon was used. The patient was admitted for dialysis conduit dysfunction. The left upper arm avf was created 8 years prior in the brachial artery and cephalic vein. Ultrasonography revealed severe stenosis of the cephalic arch with normal dilation of the left upper arm dialysis conduit. A 6fr sheath was inserted into the mid-portion of the upper arm cephalic vein. Venography revealed severe stenosis of the cephalic arch. A guidewire was passed through the stenotic lesion and pta was performed using a fortrex balloon. It is reported prior to applying burst pressure, the balloon catheter ruptured with partial vein tearing. Venotomy of the puncture site was immediately performed to remove the ruptured balloon catheter. Subsequently, 8-mm balloon tamponade in the cephalic arch was performed for 10 minutes. After confirming hemostasis of the cephalic arch with venography, the venotomy site was closed. The patient was admitted for 7 days because of left chest wall swelling and mild hematoma.

 
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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 
EI  
091708734
MDR Report Key10968411
MDR Text Key220634584
Report Number2183870-2020-00426
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK142654
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 12/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received11/18/2020
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: 12/08/2020 Patient Sequence Number: 1
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