It was reported that after opening a 2.75x15mm trek balloon dilatation catheter (bdc), it was noted that although the device was present, the balloon and protective sheath were missing from the device and not found anywhere.The device was not used and there was no patient involvement.An unspecified balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaints.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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