(b)(4).(b)(6).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is considered user preference issue as the product met specification but the user was reportedly dissatisfied with the function, performance, or appearance of the product.(b)(4).
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It was reported that product sterility was compromised.The emerge balloon catheters are packaged in a way that upon opening, they jump from the sterile inner package to the unsterile outer package, becoming contaminated.This happens outside of the patient during preparation, with no patient contact.No complications were reported.
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