Model Number H7493941820350 |
Device Problems
Deflation Problem (1149); Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2022 |
Event Type
malfunction
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Event Description
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It was reported that deflation failure occurred and removal difficulties were encountered.A 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent balloon could not be retracted normally inside the guide catheter and it was difficult to deflate.The procedure was completed with this device.There were no patient complications nor injuries reported.
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Manufacturer Narrative
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Device evaluated by mfr: synergy xd mr us 3.50 x 20mm stent delivery system was returned for analysis.The device was returned without the stent as it was implanted at the lesion site.The balloon cones were reviewed, and signs of positive pressure applied to them were noted as the balloon folds were noted to be relaxed and crimp stent markings were visible on the balloon body.The distal balloon cone was noted to be bunched.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found an inner shaft bunching at 6.7 cm proximal to distal tip as well as a shaft polymer extrusion stretch measured at 24 cm from distal tip.Device to device interaction: a test guidewire was introduced through tip but could not be tracked due to the inner shaft bunching.Therefore, the device could not be advanced over the wire and through a test guidecatheter to verify the inability to be removed through a guide allegation.An encore inflation device was attached the balloon was inflated without issues.A vacuum was pulled using the encore device and the balloon delated fully in 21s.No other issues noted with device.
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Event Description
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It was reported that deflation failure occurred and removal difficulties were encountered.A 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent balloon could not be retracted normally inside the guide catheter and it was difficult to deflate.The procedure was completed with this device.There were no patient complications nor injuries reported.
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Search Alerts/Recalls
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