N
Patient 1
IT WAS REPORTED THAT THE OPERATING (OR) TOWEL SHED LINT DURING AN UNIDENTIFIED CATH LAB PROCEDURE. PER THE FACILITY, LINTING WAS DISCOVERED ON AN UNIDENTIFIED DEVICE AFTER IT WAS WIPED WITH THE TOWEL. IT IS UNKNOWN AT WHAT POINT IN THE PROCEDURE THE REPORTED TOWEL LINTING OCCURRED. PER THE FACILITY, THERE WAS NO EFFECT ON PATIENT STABILITY. NO IMPACT TO THE PROCEDURE WAS REPORTED. NO SERIOUS INJURY, FOLLOW-UP CARE, OR MEDICAL INTERVENTION WAS REPORTED. A SAMPLE WAS RECEIVED BY THE MANUFACTURER AND THE REPORTED PRODUCT ISSUE WAS CONFIRMED. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE FACILITY CONTACT WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. DUE THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.