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Catalog Number CRE14S |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The catalog number identified in section has not been cleared in the us but is similar to the crosser cto recanalization catheters products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheters products are identified.(expiry date: 08/2022).
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Event Description
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It was reported that during a re canalization procedure of highly calcified lesion in the superficial femoral artery, the tip was allegedly detached and stuck.The procedure was completed using with another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the device was not returned for evaluation.Therefore, the investigation will remain inconclusive for the reported tip detachment.A definitive root cause could not be determined labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the crosser cto recanalization catheters products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheters products are identified in d2 and g5.H10: d4 (expiry date: 08/2022).H3 other text : device not returned.
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Event Description
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It was reported that during a re canalization procedure of highly calcified lesion in the superficial femoral artery, the tip was allegedly detached and stuck.The procedure was completed using with another device.There was no reported patient injury.
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Search Alerts/Recalls
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