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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
Model Number AB35W06040080
Device Problems Burst Container or Vessel (1074); Fracture (1260); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem Rupture (2208)
Event Date 11/14/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use an evercross pta balloon with a 6fr sheath and 0. 035 non-medtronic wire during treatment of a fibrous lesion in a proximal right upper arm fistula graft. Vessel diameter reported as 6mm. Lesion exhibited 90% stenosis. Slight tortuosity reported. Ifu was followed. No packaging issues noted prior to use. No issues noted when removing the device from the packaging. The device was prepped without issue. The device was not passed through a previously deployed stent. Resistance was encountered during advancement, but no excessive force was used. An inflation device was used with 1:3, contrast: saline mix for balloon inflation. It is reported that a circumferential/radial balloon burst occurred during first inflation at pressure of 14atm. The balloon remained on the wire. The sheath was upsized to 9fr and a snare was advanced down beside existing wire and snare end of wire and pull everything out together. It is believed that the staples from placement of synthetic graft may have been what ruptured the balloon. Slight resistance was felt while trying to remove balloon after rupture. Gentle pressure was applied as resistance is expected with a ruptured balloon. Once the balloon was removed it was discovered that the catheter had fractured and that the distal segment was still in the patient and could be seen under fluoroscopic imaging. A non-medtronic pta balloon was used which also ruptured and ruptured the vessel. A non-medtronic stent was then used to cover the ruptured segment.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: the fractured segment of the evercross catheter was removed using a snare. All fragments of the evercross balloon were removed from the patient. 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 Key9327539
MDR Text Key168598841
Report Number2183870-2019-00542
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB35W06040080
Device Catalogue NumberAB35W06040080
Device Lot NumberA888211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2019
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: 11/15/2019 Patient Sequence Number: 1
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