Model Number 20226 |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/27/2020 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.A 10.0 x 40 x 135 cm express ld stent was deployed.Upon removal, the balloon became caught in the sheath and the shaft broke.The device was removed and no further complications were reported.
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Event Description
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It was reported that shaft break occurred.A 10.0x40x135 cm express ld stent was deployed.Upon removal, the balloon became caught in the sheath and the shaft broke.The device was removed and no further complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: an express ld stent 10x40x135 was received for analysis.The recommended introducer sheath size for this express ld device as per express specification is a 7fr.The distal section of the device was received inside the customer's 7fr sheath.For investigation purposes the investigator removed the device section from the customer's sheath.A visual examination identified that the balloon had been subjected to positive pressure.Blood was identified inside the balloon which is evidence of a device leak.The balloon could not be inflated due to a shaft break.No issues were noted with balloon that could potentially have contributed to the complaint incident.A visual and microscopic examination found the stent to have been deployed from the device.The stent was not returned for analysis as it had been implanted inside the patient.A visual and tactile examination found the shaft of the device to be detached at the proximal of the balloon sleeve.This type of damage is consistent with excessive tensile force being applied to the device.No other issues were identified with the shaft.A visual and microscopic examination of the device identified no issues with the markerbands or tip that could have contributed to the complaint incident.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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