Model Number M004CRBS3050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Fistula (1862); Hematoma (1884); Impotence (1925); Pain (1994)
|
Event Date 10/22/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
|
|
Event Description
|
Clinical study (b)(6).It was reported that following a cryoablation procedure with a polarsheath, the patient experienced a femoral arterio-venous fistula with moderate impact.The patient's anticoagulant medication was stopped.The event was ongoing.Four days later, the patient was hospitalized due to the ongoing event.The hematoma was in the process of resorption with no sign of leg hypo perfusion.However, persistent femoral murmur was present.The patient also experienced "functional impotence." the patient was given oral paracetamol and their apixaban oral medication was stopped.Two days later, the apixaban was restarted with a decreased dose.The event was ongoing.The suspected cause was the ablation procedure.The device is not expected to be returned.
|
|
Event Description
|
Clinical study polar ice py003.It was reported that following a cryoablation procedure with a polarsheath, the patient experienced a femoral arterio-venous fistula with moderate impact.The patient's anticoagulant medication was stopped.The event was ongoing.Four days later, the patient was hospitalized due to the ongoing event.The hematoma was in the process of resorption with no sign of leg hypo perfusion.However, persistent femoral murmur was present.The patient also experienced "functional impotence." the patient was given oral paracetamol and their apixaban oral medication was stopped.Two days later, the apixaban was restarted with a decreased dose.The event was ongoing.The suspected cause was the ablation procedure.The device is not expected to be returned.It was further reported that the patient experienced pain on the right femoral fistula.An echo doppler showed the fistula was still present.The patient's pain was also still present.The patient was scheduled for surgery.
|
|
Manufacturer Narrative
|
It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
|
|
Manufacturer Narrative
|
It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
|
|
Event Description
|
Clinical study polar ice (b)(4): it was reported that following a cryoablation procedure with a polarsheath, the patient experienced a femoral arterio-venous fistula with moderate impact.The patient's anticoagulant medication was stopped.The event was ongoing.Four days later, the patient was hospitalized due to the ongoing event.The hematoma was in the process of resorption with no sign of leg hypo perfusion.However, persistent femoral murmur was present.The patient also experienced "functional impotence." the patient was given oral paracetamol and their apixaban oral medication was stopped.Two days later, the apixaban was restarted with a decreased dose.The event was ongoing.The suspected cause was the ablation procedure.The device is not expected to be returned.It was further reported that the patient experienced pain on the right femoral fistula.An echo doppler on 19nov2020 showed the fistula was still present.The patient's pain was also still present.The patient was scheduled for surgery on (b)(6) 2020.It was further reported that the patient was admitted to the hospital on (b)(6) 2020 and surgery was performed on (b)(6) 2020 and the event resolved.
|
|
Search Alerts/Recalls
|