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Device Problem
Burst Container or Vessel (1074)
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Patient Problems
Pulmonary Embolism (1498); Dyspnea (1816); Anxiety (2328); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/31/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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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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Search Alerts/Recalls
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