Catalog Number EUP2512X |
Device Problems
Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
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Patient Problems
No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
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Event Date 02/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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Reference number: mw5078443 initial reporter occupation: other health care professional (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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During a cardiac intervention procedure an attempt was made to use one euphora semi compliant balloon catheter to treat a lesion.It was reported that during preparation the technologist removed the wire at the balloon end of the catheter.The protective sheath covering the balloon stayed in place on the catheter.The catheter was inserted into the groin of the patient and maneuvered to the coronary vessels where the protective sheath/covering came off in the patient.
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Manufacturer Narrative
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Additional information: it is indicated that the person prepping the device was in training with an experienced technologist.The protective sheath was compressed by a coronary stent.Patient is doing fine with no reported injuries.If information is provided in the future, a supplemental report will be issued.
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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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction to aware date for previously submitted additional information.The correct aware date for report # 9612164-2018-01969 is the (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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