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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB35W08060080
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Stenosis (2263); Patient Problem/Medical Problem (2688)
Event Date 11/02/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient is a former smoker with a medical history of hypertension, diabetes, renal insufficiency and carotid artery disease. During the index procedure one evercross 8mmx60mm balloon was used with an inpact admiral dcb to treat the swing point of the left arm ((b)(6) 2017). Approximately 2 months post index procedure the patient suffered from excessive bleeding from fistula post dialysis ((b)(6) 2018). The event was described as avf stenosis and repair. Fistulogram corrected the issue. A fistulogram was performed and the swing point was treated with a non-mdt pta. The patient recovered. Approximately 6 months post procedure ((b)(6) 2018), patient suffered left avf bleeding and was treated with coumadin, two sutures, surgical intervention and revascularization of the swing point with non-medtronic pta ((b)(6) 2018). Approximately 11 months post procedure ((b)(6) 2018), patient suffered malfunction of the left upper extremity fistula, the patient was treated with revascularization of the venous outflow with non-medtronic pta ((b)(6) 2018).
 
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.
 
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Brand NameEVERCROSS 035
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 Key8477179
MDR Text Key140742444
Report Number2183870-2019-00154
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/09/2020
Device Catalogue NumberAB35W08060080
Device Lot NumberA488577
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 Received05/06/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/10/2017
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: 04/03/2019 Patient Sequence Number: 1
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