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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 AB35W06040080
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Date 09/09/2017
Event Type  Injury  
Manufacturer Narrative
Evaluation summary the evercross dilatation catheter was returned for evaluation. A portion of 6mm by 40mm balloon chamber material, inner guidewire lumen approximately 40mm including the distal tip, and two balloon chamber radiopaque marker bands were not returned. No ancillary devices or cine images from the procedure were received. The balloon chamber material separation face appears to be a radial tear within the proximal balloon chamber cone and the inner guidewire lumen separation exhibits a tensile separation at the proximal end of the proximal radiopaque marker band. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Event description updated with additional information inflation atm was reported as 8 atm which is below the rbp for this device (14 atm) a 6fr sheath and a 0. 035 guidewire was used in the procedure no embolic protection was used the physician used a new balloon and it worked with no issues reported. If information is provided in the future, a supplemental report will be issued.
 
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 catheter in a patient when the balloon burst. The balloon was removed from the patient but a portion of the balloon remained in the patient. A stent was deployed to jail the balloon fragment against the wall of the artery.
 
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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 Key6915750
MDR Text Key100534184
Report Number2183870-2017-00426
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/05/2019
Device Catalogue NumberAB35W06040080
Device Lot NumberA322765
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2016
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: 10/05/2017 Patient Sequence Number: 1
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