Catalog Number M0035473080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Embolus (1830)
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Event Date 12/05/2017 |
Event Type
Injury
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Manufacturer Narrative
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The subject device is not available.
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Event Description
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During a coil embolization procedure, two coils could not be inserted into the hub of the microcatheter; the case was completed successfully using other coils.It was further reported that the patient had a distal emboli shown on his final angiogram and the physician was unsure if this was related to the coils.No further information is available.
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Manufacturer Narrative
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Product available to stryker corrected to reflect the device is not available.The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis, therefore physical and functional tests could not be performed.However, patient embolus is a known risk associated with endovascular procedures and is noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.The subject device is not available.
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Event Description
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During a coil embolization procedure, two coils could not be inserted into the hub of the microcatheter; the case was completed successfully using other coils.It was further reported that the patient had a distal emboli shown on his final angiogram and the physician was unsure if this was related to the coils.No further information is available.
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Manufacturer Narrative
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Product available to stryker ¿ device was received, corrected to ¿return¿.The subject device was received.Analysis of the returned device found the delivery wire and the main coil were kinked/bent, and resistance was encountered in the sheath during functional testing.Based on device analysis and the information available, the damage to the device was likely the result of a deviation from directions for use (dfu), as reported by the user.There was no change to the investigation conclusion after device analysis as the reported patient embolus is a known risk associated with endovascular procedures and noted as such in the device dfu.Therefore, adverse event related to procedure was assigned to this event.
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Event Description
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During a coil embolization procedure, two coils could not be inserted into the hub of the microcatheter; the case was completed successfully using other coils.It was further reported that the patient had a distal emboli shown on his final angiogram and the physician was unsure if this was related to the coils.No further information is available.
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Search Alerts/Recalls
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