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Catalog Number RBYPODJ45 |
Device Problems
Detachment Of Device Component (1104); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/24/2017 |
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.This report is associated with mfr report numbers: 3005168196-2017-02258, 3005168196-2017-02259, 3005168196-2017-02260.The hospital disposed of the device.
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Event Description
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The patient was undergoing a coil embolization procedure in the splenic artery using pod packing coils (podjs), pod8s and pod6s.It was noted that the patient anatomy was tortuous.During the procedure, while attempting to advance a podj through a non-penumbra microcatheter, the physician experienced resistance and decided to remove the podj; however, upon retraction, the podj unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached coil was removed and the coil was flushed out.After that, the microcatheter was reinserted into the patient¿s body; however, it was reported that the same issue occurred with another podj, a pod8 and a pod6.The procedure was completed using additional podj coils and the same microcatheter.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2017-02257.This report is associated with mfr report numbers: 3005168196-2017-02258, 3005168196-2017-02259, 3005168196-2017-02260.
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Search Alerts/Recalls
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