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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 AB35W10040080
Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 10/12/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician was attempting to use an evercross pta balloon during an upper extremity fistulogram. The physician first dilated the balloon to nominal pressure with lack of resolution of the stenosis. It was reported the balloon was then dilated to less than burst-pressure and the balloon ruptured in the midline in a transverse manner (not along the long axis of the balloon). There were 2 free ends of the balloon still located on the treatment wire. The balloon could not be removed through the sheath. A snare catheter was advanced to the end of the most central end of the balloon, while keeping on the wire, and the entire system, including the sheath, was withdrawn over the wire. The procedure then proceeded, and the patient was treated without rupture of the vessel. No further patient injury was reported.
 
Manufacturer Narrative
Evaluation summary: the evercross dilatation catheter was received for evaluation. No ancillary devices or cine images from the procedure were received. The evercross dilatation catheter was received in two segments. The manifold-catheter-proximal balloon chamber segment was approximately 74. 8cm in length from the distal tip of the manifold strain relief. The proximal balloon chamber material exhibited both longitudinal and radial tearing. The proximal balloon marker band was present. The guidewire lumen separation was at the distal end of the marker band. The inner guidewire lumen from the balloon chamber was approximately 8. 3cm in length and included the balloon¿s distal marker band. The guidewire lumen exhibited tension stretching and necking. The distal marker band exhibited lateral compression. All components of the device were accounted for. 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 Key7275185
MDR Text Key100235056
Report Number2183870-2018-00094
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
Report Date 03/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/17/2020
Device Catalogue NumberAB35W10040080
Device Lot NumberA510798
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2017
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: 02/15/2018 Patient Sequence Number: 1
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