A1: patient identifier: retainedwire.A2: date of birth: requested, not provided.A5: ethnicity: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: rtr cv lab manager.A review of the device history record of the product code and lot number combination was conducted with no findings.The actual device was not available for return; therefore, an evaluation of the actual device was unable to be conducted.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
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Terumo medical received an fda medwatch report # mw5115543.The event description states: patient was admitted for outpatient interventional radiology (ir) for staged procedures.At the completion of the arteriogram, embolization prior to cryoablation, a small metallic foreign body was seen persisting in the region of intervention on review of imaging films.After cessation of the procedure, separate radiographs of the pelvis and right hip were obtained, as well as a focused ultrasound, demonstrating an apparent retained section of wire within the subcutaneous tissues.Superficial to the right femoral artery and vein, normal flow was established at the right common femoral artery and vein.Retrieval was felt to be more traumatic than the potential for complications, therefore no retrieval attempt was made at the time.Subsequent attempt to remove the foreign body later was unsuccessful.Additional information was received on 21 mar 2023: the broken wire was confirmed to still be within the patient.The date of the attempt to remove the wire was (b)(6) 2022.The patient was in stable condition.Additional information was received on 22 mar 2023: there was no harm to the patient's organs or vessels.
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