The catalog number identified in section d4 has not been cleared in the us but is similar to the power port isp m.R.I., 8fr groshong that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong are identified.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one powerport mri isp implantable port, one flushing connector and one cath-lock attached to a groshong catheter, one introducer needle, one straight non-coring needle, one right-angle non-coring needle, one vein pick, one cath-lock, one syringe, one j-tip guidewire in a guidewire hoops, one 8.0fr introducer peel-apart sheath and vessel dilator, one safety infusion set, one tunneler and one guidewire loaded in a guidewire hoop were returned for evaluation.Gross, microscopic visual and functional testing were performed.The investigation is confirmed for the identified guidewire deformation issue as the guidewire appeared to be bend on the distal tip.However, the investigation is inconclusive for the reported difficulty in insertion issue as the exact circumstances at the time of reported event was unknown and the clinical conditions cannot be replicated to confirm these failures.Furthermore, the investigation is unconfirmed for reported peeled issue as no peeling was noted on the received physical sample.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.(expiration date: 08/2023).
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