The catalog number identified has not been cleared in the us but is similar to the power port isp m.R.I., 8fr groshong products that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong products are identified.Manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one guidewire in a guidewire hoop was returned for evaluation.Visual evaluation was performed on the returned device.One spacer of the guide-wire hoop was returned broken in two pieces.The investigation is confirmed for the identified fracture and material separation as one of the spacer of the guidewire hoop was broken.However, the investigation is inconclusive for the reported guide-wire hoop spacer damage upon opening the package as the exact circumstances at the time of opening the package are unknown.The definitive root cause could not be determined based upon 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.
|