It was reported that when inserting the microintroducer into the patient, the operator found its edges were uneven, unable to continue puncturing.Therefore, the microintroducer was removed and replaced with a new one.
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H11: section a through f - 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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged microintroducer is confirmed but the exact cause remains unknown.One 4.5 fr microez microintroducer was returned for evaluation.The grey sheath had not been peel and was returned with the dilator present.Blood residue was visible within the device.Microscopic observation of the sheath tip revealed it to be bunched inwards with the orifice flared outwards.The bunching was present on two regions of the sheath tip.Additional deformation was also present along the shaft.Based on the damage observed, possible contributing factors include advancement against resistance and inadequate skin knick.The product instructions for use (ifu) states, ¿advance the small sheath and dilator together as a unit over the guidewire, using a slight rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.Verify institutional guidelines concerning the use of a scalpel prior to making incision.¿ since the sheath tip was observed to be damaged, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.
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It was reported that when inserting the microintroducer into the patient, the operator found its edges were uneven, unable to continue puncturing.Therefore, the microintroducer was removed and replaced with a new one.
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