Model Number 26924 |
Device Problems
Entrapment of Device (1212); Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2024 |
Event Type
malfunction
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Event Description
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It was reported that device entrapment and premature deployment occurred.The patient underwent percutaneous transluminal angioplasty and stenting of the 90% stenosed target lesion located in the severely tortuous and severely calcified superficial femoral artery via contralateral approach.A 6f 45cm catapult guide sheath was advanced with difficulty over the iliac bifurcation followed by crossing a 035 non-boston scientific (bsc) guidewire into the lesion.Pre-dilatation was performed with a 5 x 220 sterling balloon catheter with 60% residual stenosis.A 6 x 60 x 130 innova vascular stent was advanced for treatment.It was noted that the guidewire was flushed with heparinized saline.However, during insertion, the stent got stuck on the guidewire and started to deploy outside the patient before ever getting into the sheath.The stent and the guidewire had to be removed together due to the wire being stuck in the sheath.The procedure was completed with a stiff zipwire and a 6 x 80 innova vascular stent.No patient complications were reported.
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Manufacturer Narrative
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The device was returned for evaluation.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent is partially deployed 28mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The pull rack and yellow thumbwheel lock is still in the manufactured position.Device to device interaction test was performed and the device was able to track over a test guidewire with some resistance at the kinked location.Inspection of the remainder of the device, revealed no other damage or irregularities.No other issues were identified during the product analysis.
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Event Description
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It was reported that device entrapment and premature deployment occurred.The patient underwent percutaneous transluminal angioplasty and stenting of the 90% stenosed target lesion located in the severely tortuous and severely calcified superficial femoral artery via contralateral approach.A 6f 45cm catapult guide sheath was advanced with difficulty over the iliac bifurcation followed by crossing a 035 non-boston scientific (bsc) guidewire into the lesion.Pre-dilatation was performed with a 5 x 220 sterling balloon catheter with 60% residual stenosis.A 6 x 60 x 130 innova vascular stent was advanced for treatment.It was noted that the guidewire was flushed with heparinized saline.However, during insertion, the stent got stuck on the guidewire and started to deploy outside the patient before ever getting into the sheath.The stent and the guidewire had to be removed together due to the wire being stuck in the sheath.The procedure was completed with a stiff zipwire and a 6 x 80 innova vascular stent.No patient complications were reported.
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Search Alerts/Recalls
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