Model Number 44150 |
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 08/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter name and address: (b)(6).
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Event Description
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It was reported that removal difficulty was encountered.The target lesion was located in the internal carotid artery.A 10.0-31 carotid wallstent was implanted for treatment.A sterling balloon catheter was approached into the stent after implantation of the device for post- dilatation.However, a resistance was felt at the proximal, midline, and distal part of the stent.The ivus (opticross) was also used and resistance was also observed.It was attempted to lift the recovery sheath during recovery of the filterwire ez, however, it got stuck and could not be lifted.The physician managed to perform recovery while changing the guiding position.The inside of the guiding catheter was aspirated after recovering the filterwire ez, and a v-shaped metal fragment at the tip was recovered.The procedure was completed with the original device.No patient complications were reported.The patient is doing well.
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Manufacturer Narrative
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E1- initial reporter city: (b)(6).D4 - expiration date: updated to 11/24/2023.D4 - unique identifier (udi) #: (b)(4).G1 - mfr site address 1: updated from ballybrit business park to 2546 calle primera.G1 - mfr site city: galway to alajuela.G1 - mfr site country: updated from ireland to costa rica.H4 - device manufacture date: updated to 11/24/2021.
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Event Description
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It was reported that removal difficulty was encountered.The target lesion was located in the internal carotid artery.A 10.0-31 carotid wallstent was implanted for treatment.A sterling balloon catheter was approached into the stent after implantation of the device for post- dilatation.However, a resistance was felt at the proximal, midline, and distal part of the stent.The ivus (opticross) was also used and resistance was also observed.It was attempted to lift the recovery sheath during recovery of the filterwire ez, however, it got stuck and could not be lifted.The physician managed to perform recovery while changing the guiding position.The inside of the guiding catheter was aspirated after recovering the filterwire ez, and a v-shaped metal fragment at the tip was recovered.The procedure was completed with the original device.No patient complications were reported.The patient is doing well.
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Search Alerts/Recalls
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