Model Number 80619 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(6).
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Event Description
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It was reported that removal difficulty occurred.The target lesion was located in the severely tortuous and non-calcified inferior mesenteric artery.A straight/130 direxion hi-flo catheter-fusion was selected for use.During the procedure, the device was inserted into a 5 french non-boston scientific angiographic catheter but could not be inserted further from the middle and it got stuck.The device was removed from the angiographic catheter by pulling it hard as there were severe resistance encountered.A kink was noted when the device was removed.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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A2 - age at time of event: 18 years or older.E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device shaft was analyzed for any damage.The devices shaft showed 1 fracture located 118.5cm from the hub.The shaft was not completely separated the inner liner was still connected.No other damage was noticed on the catheter shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No kinks were confirmed; however, a fracture was confirmed.
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Event Description
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It was reported that removal difficulty occurred.The target lesion was located in the severely tortuous and non-calcified inferior mesenteric artery.A straight/130 direxion hi-flo catheter-fusion was selected for use.During the procedure, the device was inserted into a 5 french non-boston scientific angiographic catheter but could not be inserted further from the middle and it got stuck.The device was removed from the angiographic catheter by pulling it hard as there were severe resistance encountered.A kink was noted when the device was removed.The procedure was completed with a different device.No patient complications were reported.
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Search Alerts/Recalls
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