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Model Number 46098-75 |
Device Problem
Component(s), broken (1103)
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Patient Problems
Distress (2329); Vascular System (Circulation), Impaired (2572)
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Event Date 01/15/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A review of the complaint database for this list#, lot# and similar issue recorded no additional reports.Findings: the involved 46098-75 device was not returned for analysis and confirmation.The exact causes of the reported event or the post incident/post procedure observation of a 46098-75 component (manifold) damage are unknown.
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Event Description
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Maude report received concerning component damage with use of 46098-75 cath lab kit.The report describes the event as follows "during an elective pci patient became nauseous and developed chest pains.Imaging post stent deployment showed that the patient had lost distal circulation on the left side.Patient was treated with intra-coronary nitroglycerin and iv zofran.Flow was restored and symptoms improved.Post procedure it was determined that the single manifold was cracked and had let some air in with the injection." the 46098-75 device would have been pre-tested/primed prior to use.During the emergent activity medications were successfully delivered/administered, patient returned to baseline condition and procedure resumed.The 46098-75 device remained in use with no reported device performance/functional issues encountered.Follow up with the facility for additional information as well as the return status of the 46098-75 device reports the device is not available and no additional information other than what was on the maude report.
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Search Alerts/Recalls
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