BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Model Number 38270 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Coma (2417); Device Embedded In Tissue or Plaque (3165)
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Event Date 10/18/2019 |
Event Type
Death
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Event Description
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It was reported that catheter tip was fractured and detachment encountered.A ii/5/bern/100/038 bx5 imager ii angiograpic catheter was selected for use in the internal carotid artery.However, during the procedure, it was noted that the tip of the catheter was fractured and detached.The physician tried to withdraw the fractured catheter at once but failed.The length of the catheter that remained in the patient's body was 2.8cm.The physician tried to remove the fractured part with a snare but failed.There were no patient complications as this time and the patient was stable.Approximately 5 hours after device use, the patient experienced decreased respiratory heart rate, low blood pressure, and was on assisted breathing with upper tracheal intubation.After rescue, the patient was temporarily stable and was transferred to icu 30 minutes later.The patient was transferred to other hospital.
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Event Description
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It was reported that catheter tip was fractured and detachment encountered.A ii/5/bern/100/038 bx5 imager ii angiograpic catheter was selected for use in the internal carotid artery.However, during the procedure, it was noted that the tip of the catheter was fractured and detached.The physician tried to withdraw the fractured catheter at once but failed.The length of the catheter that remained in the patient's body was 2.8cm.The physician tried to remove the fractured part with a snare but failed.There were no patient complications as this time and the patient was stable.Approximately 5 hours after device use, the patient experienced decreased respiratory heart rate, low blood pressure, and was on assisted breathing with upper tracheal intubation.After rescue, the patient was temporarily stable and was transferred to icu 30 minutes later.The patient was transferred to other hospital.It was further reported that the patient sank into the coma when the physician tried to snare the device fragment.
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Event Description
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It was reported that catheter tip was fractured and detachment encountered.A ii/5/bern/100/038 bx5 imager ii angiographic catheter was selected for use in the internal carotid artery.However, during the procedure, it was noted that the tip of the catheter was fractured and detached.The physician tried to withdraw the fractured catheter at once but failed.The length of the catheter that remained in the patient's body was 2.8cm.The physician tried to remove the fractured part with a snare but failed.There were no patient complications as this time and the patient was stable.Approximately 5 hours after device use, the patient experienced decreased respiratory heart rate, low blood pressure, and was on assisted breathing with upper tracheal intubation.After rescue, the patient was temporarily stable and was transferred to icu 30 minutes later.The patient was transferred to other hospital.It was further reported that the patient sank into the coma when the physician tried to snare the device fragment.It was further reported that the patient died.
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