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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
Device Problem Burst Container or Vessel (1074)
Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Anxiety (2328); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/31/2019
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

A journal article was submitted detailing a patient case report. Medtronic¿s evercross pta balloon and gooseneck snare devices were used. The patient underwent balloon angioplasty of the left avg which has been placed 2 years previously in the brachial artery and axillary vein. The evercross pta balloon was inflated to burst pressure for 3 minutes in the tight stenotic venous anastomotic site and ruptured. A removal attempt was made through the femoral sheath, the balloon catheter was jammed and fell apart via the right femoral approach site. The migrated tip was stuck at the left upper interlobar pulmonary artery. Initially the remaining balloon catheter was removed by cutdown of the femoral vein. Subsequently, via the left main pulmonary artery using bent-tip angiocatheters with guidewire passage an attempt was made to recapture the ruptured balloon catheter tip using a gooseneck snare. Despite several trials, the balloon tip was buried deeper into the left main pulmonary artery. The balloon tip was removed from the pulmonary artery by open thoracotomy because the patient had complained of mild dyspnea and anxiety. Lateral thoracotomy was performed by the thoracic surgeon to remove the embolized balloon tip. The patient was discharged without complication after 7 days. A new avg was inserted in the right arm after 2 months.

 
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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 
EI  
091708734
MDR Report Key10967923
MDR Text Key220425009
Report Number2183870-2020-00421
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 12/08/2020 Patient Sequence Number: 1
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