(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
(b)(4).
The device was received.
Investigation is not yet complete.
A follow up report will be submitted with all additional relevant information.
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It was reported that the procedure was to treat a lesion located in the distal left anterior coronary artery that was mildly tortuous and less than 10% calcified.
The nc trek 3.
25 x 20 mm balloon was advanced and prepped inside the patient, however, during preparation, a leak was observed from the balloon.
Resistance was felt during advancement to the lesion with the guiding catheter.
During removal, resistance was felt and the proximal shaft of the balloon dilatation catheter (bdc) separated.
Another balloon catheter was advanced to trap the separated portion in the introducer sheath and the entire system was removed as a single unit.
It was confirmed that no separated portion was left in the patient.
Another bdc was used to complete the procedure.
There was no reported adverse patient effect.
There was no reported clinically significant delay in the procedure.
No additional information was provided.
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(b)(4).
Evaluation summary: the device was returned for analysis.
Visual inspections were performed on the returned device.
The shaft separation was confirmed.
The difficult to position, leak, and difficult to remove could not be replicated in a testing environment due to the condition of the returned device.
The investigation was unable to determine a conclusive cause for the reported difficulties.
It should be noted the nc trek rx coronary dilatation catheter instructions for use states: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise complications may occur.
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 from this lot.
Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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