The user facility reported that when the 000150 guidewire was removed during a procedure, it was noticed to be bent.The procedure was completed with no surgical delays or patient injury.Although multiple attempts have been made, no additional information regarding patient status or procedure has been provided.This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.
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Although multiple attempts were made to gather additional information and for the return status of the reported device to conmed, neither has been provided by the facility; therefore, the reported failure could not be verified and a root cause cannot be conclusively determined.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A review of this lot number showed no other complaint for this lot product, with 138 pieces manufactured, and event description.A two-year review of complaint history revealed 9 other similar complaints for this product family and failure mode.In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this failure 0.042 percent, if all complaints were confirmed.The instructions for use advises the user of the following.The guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.Inspect the flexible spring tip and discard the wire if the tip appears to be bent or fatigued.Also inspect the soldered joints and discard the wire of the soldered joints appear discolored, lose or cracked.This issue will continue to be monitored through the complaint system to assure patient safety.
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