The catalog number identified has not been cleared in the us, but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is identified in common device name and date received by manufacturer.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one j-tip guidewire loaded to a guidewire hoop was returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported stretched issue and the identified deformation due to compressive stress, and fracture issues, as the flat core wire was noted to have a complete break within the guidewire coils.Uncoiling of the guidewire was observed in a portion distal to the distal tip.The j-tip of the guidewire was noted to be bent.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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