It was reported that during a recanalization procedure to treat arterial thrombosis in the lower extremity and in the femoral-popliteal artery via a contralateral approach, leak was allegedly noted on the collection bag and abnormal suction sounds were heard.Further, it was reported that the catheter was removed and upon inspection it was found that tip of the catheter was separated from the spring of the catheter.The procedure was completed using another device.There was no reported patient injury.
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in d2 and g4.H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned to the manufacturer for evaluation and images were not provided.Therefore, the investigation is inconclusive for reported issues.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.H10: the medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations.The correct medical device manufacturer and manufacturing location are straub medical us.H10: d4 (expiry date: 12/2023), g3, h6 (method).H11: h6 (result, conclusion).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.
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