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Model Number 45007 |
Device Problem
Suction Problem (2170)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 01/28/2022 |
Event Type
Injury
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Event Description
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It was reported that a loss of aspiration occurred, and thrombosis was observed.A 2.1mm jetstream xc catheter was selected for use in the superficial femoral artery and popliteal.During the procedure, a loss of aspiration occurred, which resulted in the need for a secondary thrombectomy.After taking the device out, it was observed that the bag of saline was gone, and there was less than 1/4 of the fluid in the collection bag with minimal leakage on the table.The majority of the saline/rotaglide mix went into the patient.Thrombosis was observed and was treated with a non-boston scientific thrombectomy catheter.The patient is expected to fully recover.
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Manufacturer Narrative
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Device eval by manufacturer: returned product consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage and functional testing of the device was completed.The device showed no damage.Functional analysis was done by completing the setup procedure per the instructions for use.Aspiration testing of the device was done per the test procedure.The device is tested by using a beaker of water.The device's tip is submerged in a beaker of fluid and the device is run for a period of 1 minute.The final milliliters of fluid that the beaker shows after the 1 minute run time is subtracted from the starting milliliters, and the final number is the total that was aspirated.Test results showed that this device did not perform as designed per the test procedure specification.Inspection of the remainder of the device revealed no damage or irregularities.
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Event Description
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It was reported that a loss of aspiration occurred, and thrombosis was observed.A 2.1mm jetstream xc catheter was selected for use in the superficial femoral artery and popliteal.During the procedure, a loss of aspiration occurred, which resulted in the need for a secondary thrombectomy.After taking the device out, it was observed that the bag of saline was gone, and there was less than 1/4 of the fluid in the collection bag with minimal leakage on the table.The majority of the saline/rotaglide mix went into the patient.Thrombosis was observed and was treated with a non-boston scientific thrombectomy catheter.The patient is expected to fully recover.
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Search Alerts/Recalls
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