The catalog number identified in section has not been cleared in the us, but is similar to the sleek otw pta catheter products that are cleared in the us.The pro code for the sleek otw pta catheter products is identified.The lot number was provided for the reported malfunction; therefore, a lot history review was performed.The device was returned for evaluation.Investigation was unconfirmed for packaging issue and confirmed for the reported balloon damage.A definitive root cause has not been determined.The device is labeled for single use.
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