Model Number 8575 |
Device Problems
Break (1069); Difficult to Remove (1528); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/09/2020 |
Event Type
Injury
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Event Description
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It was reported that the surgery was required to remove the catheter.The 99% stenosed target lesion was located in the distal right coronary artery (rca).The femoral artery seemed to be tortuous just past the sheath insertion.A 6f runway al1 sh guide catheter was selected for use.After the catheter was inserted, three kinks were observed on it.The physician tried to straighten the kinks with a 0.38 wire while part of the catheter remained inside the patient.The catheter broke at the proximal section.The portion of the device inside the patient was unable to be retrieved.The patient was sent to theatre to have the al1 guide removed.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by manufacturer; returned product consisted of an incomplete runway guide catheter.The device was bloody.Analysis of the shaft and hub included microscopic and visual inspection.Inspection revealed only 17.6 cm of the shaft was returned, with a kink 33 mm from the strain relief.The distal end of the broken edge was frayed and twisted.Inspection of rest of the device did not find any other damage or defect.The reported kink and broken device was confirmed, however; the reported device jamming could not be confirmed as clinical circumstances could not be replicated.
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Event Description
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It was reported that the surgery was required to remove the catheter.The 99% stenosed target lesion was located in the distal right coronary artery (rca).The femoral artery seemed to be tortuous just past the sheath insertion.A 6f runway al1 sh guide catheter was selected for use.After the catheter was inserted, three kinks were observed on it.The physician tried to straighten the kinks with a 0.38 wire while part of the catheter remained inside the patient.The catheter broke at the proximal section.The portion of the device inside the patient was unable to be retrieved.The patient was sent to theatre to have the al1 guide removed.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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