Only the zoom 71 catheter was returned for investigation.Upon investigation it was determined that there was shaft breakage at the distal end.Investigation demonstrated stretching, buckling, and kinking of the catheter.Based on the information obtained, no case images provided, and return of the zoom71 catheter only the exact root cause of shaft breakage could not be determined.The manufacturing records were reviewed, and demonstrated the product met all the design and manufacturing specifications.
|