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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 Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/10/2017
Event Type  Injury  
Manufacturer Narrative
Additional information received: physician employed the use of an evercross pta balloon catheter with a 7fr non-mdt sheath and non-mdt inflation device for the treatment of a native heavily calcified pseudoaneurysm in the common iliac artery. Access was from both sides retrograde, intervention was made from the right side. Vessel diameter reported as being 9mm. This balloon was passed through a previously deployed stent. Balloon was inflated to a pressure of 12 atm's once. Physician experienced difficulties when attempting to deflate the balloon as it would not deflate. Physician then observed that blood was going back into the inflation device when it was under vacuum, but the device was not inflating. Physician then made another puncture in the patients treated vessel close to the introducer. Physician had to puncture the balloon to release pressure, so it could be removed from the patient. It was reported no pieces of balloon were left in the patient. Patient is reported as being fine. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Cines were received contained six dicom image folders. Five of the folders contain single images of the abdominal aortic and common iliacs from different times in the procedure. The sixth folder contains exam protocol spread sheet. Cine image 1 shows measurement of the targeted common iliac artery. A guidewire and support sheath can be identified in the cine image. Cine image 2 shows an expanded view of the targeted common iliac artery. A guidewire can be identified in the cine image. Cine image 3 shows two stents have been implanted in the common iliac arteries. The stent in the patient¿s right common iliac artery is identified as being 14mm in diameter and 40mm in length. The stent in the patient¿s left common iliac artery is identified as being 12mm in diameter and 60mm in length. A guidewire is identified running through the right common iliac artery and into the abdominal aorta. A support sheath is identified running through the left common iliac artery and into the abdominal aorta. Cine image 4 shows the same anatomy as cine image 3 but with an injection of contrast flowing through the vessels. Cine image 5 shows a broader image of cine image 4 and the contrast flow. 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
An evercross pta balloon was used for an angioplasty procedure. It was reported a balloon burst occurred. It was not possible to retract the deflated balloon through the sheath. Due to this issue, the physician had to puncture the balloon subcutaneously. After removal of the sheath, the user observed that the main part of the balloon was detached from the wire.
 
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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 Key7116280
MDR Text Key100545698
Report Number2183870-2017-00574
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/22/2020
Device Catalogue NumberAB35W10040080
Device Lot NumberA480956
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/23/2017
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: 12/14/2017 Patient Sequence Number: 1
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