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Model Number RBYPODJ30-A |
Device Problems
Physical Resistance/Sticking (4012); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2021 |
Event Type
malfunction
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Event Description
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The patient was undergoing a coil embolization procedure in the right internal mammary arteries (rima) using pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced the pod pc in the target vessel but decided to retract the coil in order to reposition it.While attempting to retract the pod pc, the physician encountered resistance and the pod pc unintentionally detached partially in the lantern and partially in the vessel.The physician then used a snare device to remove the detached pod pc.The next pod pc also unintentionally detached within the lantern.Therefore, the lantern containing the detached pod pc was removed.The procedure was completed using new pod pcs and the same lantern.There was no report of an adverse effect to the patient.
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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 number.
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Manufacturer Narrative
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Please note that the associated report number was inadvertently missed on the initial mfr report and is being included in this follow-up #01 mfr report: 3005168196-2021-02799 this report is associated with mfr report numbers: 1.3005168196-2021-02800 h3 other text : placeholder.
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Search Alerts/Recalls
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