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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During preparation for a medical procedure, an indigo system catrx aspiration catheter (catrx) inadvertently became kinked upon removal from its sterile packaging.The damage to the catrx occurred prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new catrx.
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