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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 Problem Burst Container or Vessel (1074)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/26/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the physician was using an evercross pta balloon to treat a moderately calcified, moderately tortuous, fibrous lesion in the mid right subclavian artery. There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop. The device was prepped without issue. A 7fr non-medtronic sheath was used with no embolic protection. The device did not pass through a previously deployed stent, no resistance was encountered nor excessive force used on advancing the device to the target lesion. The device was inflated to 8atm using an inflation device and a mix of saline/contrast as inflation fluid. It was reported that the balloon burst on the first inflation and fragmented. Part of the balloon remained in the patients artery so, an 8x80x80 stent was used to cage it against the vessel wall. A new balloon was used to successfully complete the procedure. No patient injury was reported.
 
Manufacturer Narrative
The everflex se stent was used successfully to cage the device component against the vessel wall. The procedure was completed with no further issues. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Device evaluation. The catheter was received with the balloon chamber fractured from the distal tip. Visual inspection of the balloon showed a radial burst with the catheter fractured off within the balloon segment. Blood residue was observed within the fractured balloon chamber. Approximately 3. 5cm of the balloon remained on the catheter. The working length of the catheter was approximately 78. 5cm. The product label specification shows the working length is 80cm. Visual inspection under magnification of the distal edge of the catheter shows the inner guidewire lumen is separated at the distal edge of the proximal radiopaque marker band. The proximal marker band exhibits evidence of been tensely pull distal from its original position. It should be noted the distal portion of the evercrosss device which fractured off within the vessel was not returned for investigation. 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 Key8748332
MDR Text Key149644576
Report Number2183870-2019-00353
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
Report Date 09/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Catalogue NumberAB35W10040080
Device Lot NumberA840672
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2019
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: 07/01/2019 Patient Sequence Number: 1
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