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Catalog Number U5TRAP35SH |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Intimal Dissection (1333); Patient Problem/Medical Problem (2688)
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Event Date 08/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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The physician was using a dexterity diagnostic catheter during a procedure.No damage was noted to the catheter packaging.The device was removed from packaging per ifu with no issues noted.The device was inspected and prepped per ifu.No resistance was encountered when advancing the device, excessive force was not used.The catheter was used in the proximal rca, which exhibited severe tortuosity and was not calcified.During use of the dexterity a spiral dissection of the rca occurred.There was no lesion in the location of the dissection.The patient was sent for bypass surgery as the physician was unable to get wire through the dissection to treat this ae.It is reported that patient is doing fine post procedure.
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Manufacturer Narrative
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Cine image review: the reported dissection is confirmed, starting at the proximal rca and extending to the distal rca.Initial images identify a type b dissection and this developed into a type d dissection.This may have occurred due to a violent twist of the catheter during positioning or use.Due to the side holes facilitating blood passage when the artery/vessel ratio is 1:1, the position of the guide catheter and no observation of plaque during image review, the dexterity catheter catheter is not thought to have caused the dissection as a result of the location of the side holes.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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