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Catalog Number RBYPOD6 |
Device Problems
Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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Event Description
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During preparation for a coil embolization procedure, the hospital technician inadvertently kinked the hypotube of the pod6 upon removal from the packaging.The damage to the pod6 was found prior to use; therefore, the pod6 was not used in the procedure.The procedure was completed using a new pod6 and pod packing coil (podj).
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Search Alerts/Recalls
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