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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
Catalog Number A35HPV05040040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stenosis (2263); Patient Problem/Medical Problem (2688)
Event Date 09/13/2017
Event Type  Injury  
Manufacturer Narrative
Approximately 5 months post index procedure ((b)(6) 2017) patient suffered avf shunt stenosis. The event was treated with non-medtronic pta of venous outflow ((b)(6) 2018). Approximately 9 months post index procedure the patient suffered shunt stenosis ((b)(6) 2018). This was treated with medication and a non mdt pta was used to treat the anastomosis ((b)(6) 2018). The event is resolved. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: on (b)(6) 2018, approx. 13 months post the index procedure, avf shunt stenosis was reported. The patient was treated with medication and the venous outflow was treated with a non-mdt pta on (b)(6) 2018. The investigator assessed the event as not related to the index device, procedure or paclitaxel medication. The patient was reported to have recovered on (b)(6) 2018. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Approximately 17 months post index procedure the patient suffered avf shunt stenosis. The event was treated with non-medtronic pta. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: final adjudication reports that the re-intervention of the target limb was not procedure related, therapy related, or device related. The revasc has been adjudicated as being clinically driven and the location access circuit. 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 21 months post procedure the patient suffered avf shunt stenosis. This was treated with medication and a non mdt pta was used to treat the in cannulation zone. The event is resolved. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Correction of aware date (2019-07-19) for the following information. Cec adjudicated event is related to device and revascularization as a target lesion revasc. Investigator and sponsor assessed event is not related to device, procedure and paclitaxel. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Cec adjudicated the event is related to device and revascularization as a target lesion revasc. Investigator and sponsor assessed event as not related to the device, procedure or paclitaxel. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient is a non-smoker with a medical history of hyperlipidemia, diabetes, hypertension, previous revascularization of the anastomosis, coronary heart disease and renal insufficiency. During the index procedure ((b)(6) 2017) the right venous outflow lesion in the radiocephalic arteriovenous fistula (avf) was treated with a fortrex pta balloon. Approximately 2 months post index procedure ((b)(6) 2017) the patient suffered shunt stenosis at the treated lesion. The stenosis which was treated with medication and percutaneous intervention ((b)(6) 2017). The patient recovered.
 
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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 
091708734
MDR Report Key6950153
MDR Text Key119353234
Report Number2183870-2017-00447
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/19/2019
Device Catalogue NumberA35HPV05040040
Device Lot NumberA312609
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 Received07/19/2019
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 Initial

Patient Treatment Data
Date Received: 10/13/2017 Patient Sequence Number: 1
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