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: 3005168196-2021-01409.
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The patient was undergoing a coil embolization procedure in the lateral thoracic artery using ruby coil lps and a non-penumbra microcatheter.During the procedure, the physician placed the ruby coil lp in the target location using the microcatheter.Subsequently, while attempting to advance another ruby coil lp through the introducer sheath, the physician experienced resistance.The physician resheathed the ruby coil lp and tried advancing it; however, he felt resistance again.Therefore, the ruby coil lp was removed.Next, the physician decided to use another ruby coil lp and was able to deploy 90% of the ruby coil lp in the target location; however, he felt resistance and decided to adjust the microcatheter.He felt more resistance and hence decided to remove the ruby coil lp.While retracting, the ruby coil lp broke; however the coil that was deployed was sufficient for the procedure.The procedure was completed by leaving the deployed coil in the target vessel and it was the last coil used in the procedure.There was no report of an adverse effect to the patient.
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