• 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
Catalog Number A35HPV06040040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stenosis (2263); Patient Problem/Medical Problem (2688)
Event Date 09/26/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the index procedure one fortrex standard pta was used with an admiral xtreme to treat an anastomosis of the left arm ( index (b)(6) 2017). Approximately 4 months post index procedure. The patient suffered shunt stenosis and was treated with medication and pta of the venous outflow, using a fortrex balloon and an admiral xtreme ((b)(6) 2018). The patient recovered ((b)(6)2018). Update 26th april 2018: approximately 6 months post index procedure ((b)(6) 2018), the patient suffered shunt stenosis. This was treated with medication and pta of the venous outflow ((b)(6) 2018). The patient recovered. Update 10th july 2018: approximately 9 months post index procedure ((b)(6) 2018), the patient suffered avf shunt stenosis. The patient was treated with medication and target vessel revascularisation using a non-medtronic device((b)(6) 2018).
 
Manufacturer Narrative
Updated information: approximately 11. 5 months post index procedure the patient suffered avf shunt stenosis. The patient was treated with medication and target vessel revascularisation using a non-medtronic device on (b)(6) 2018. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The cec adjudicated the revascularisation as target lesion, clinically driven and related to the device but not related to the procedure or paclitaxel. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Approximately 14 months post index procedure and 10 months post revascularisation procedure, avf shunt stenosis was reported. The patient was treated with medication and revascularization of venous outflow was carried out using a non-mdt pta. Approximately 18 months post index procedure and 14 months post revascularisation procedure the patient suffered avf shunt stenosis and was treated with medication and pta of the venous outflow approximately 21. 5 months post index procedure and 16. 5 months post revascularisation procedure, the patient suffered avf shunt stenosis and was treated with medication and pta of the venous outflow. If information is provided in the future, a supplemental report will be issued.
 
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 Key7869269
MDR Text Key119976259
Report Number2183870-2018-00439
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,s
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/10/2020
Device Catalogue NumberA35HPV06040040
Device Lot NumberA443075
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 Received06/20/2019
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

Patient Treatment Data
Date Received: 09/12/2018 Patient Sequence Number: 1
-
-