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Model Number H802227680030 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Intimal Dissection (1333)
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Event Date 06/22/2017 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that the patient had vessel dissection.The target lesion was located in the left anterior descending (lad) artery.A 1.50mm rotalink¿ burr was selected for use during a left heart catheterization procedure.During procedure, a dissection of the lad in the proximal portion was observed.Furthermore, the physician removed the burr and went back in.An unspecified balloon and two unspecified stents were used to treat the dissection.After removing the burr, another two unspecified stents to were implanted to follow-up after advancing an unspecified balloon over an unspecified wire.There were no further patient complications reported and the patient's status was fine.
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Search Alerts/Recalls
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