3M¿ COBAN¿ SELF-ADHERENT WRAP

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW OF BATCH 0105563135 WAS PERFORMED AND NO NONCONFORMANCES WERE OBSERVED. THE RETAINED SAMPLES FOR SAME LOT WERE CHECKED AND NO NON-CONFORMITIES WERE FOUND. THE ROOT CAUSE OF THE ALLEGED INJURY COULD NOT BE DETERMINED. SOLVENTUM WILL CONTINUE TO MONITOR.

Additional Manufacturer Narrative

WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO PERFORM ANY TESTS TO DETERMINE IF THE DEVICE MET SPECIFICATIONS. WITHOUT ADDITIONAL INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE ALLEGED INJURY OR WHETHER THE 3M COBAN SELF-ADHERENT WRAP WAS THE ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW IS PENDING COMPLETION.

Description of Event or Problem

A PATIENT WAS DIAGNOSED WITH CORONARY ARTERY DISEASE AND UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) ON (B)(6) 2024. AFTER THE PROCEDURE, THE 3M COBAN SELF-ADHERENT WRAP, 1584, WAS APPLIED TO THE PUNCTURE WOUND. ON (B)(6) 2024, THE DOCTOR CHECKED THE PATIENT AND UPON REMOVAL OF THE 3M COBAN SELF-ADHERENT WRAP, SCATTERED BLISTERS WERE OBSERVED. THE LARGEST BLISTER WAS 4CM X 3CM. THE BLISTERS WERE DRAINED AND STERILIZED WITH POVIDONE-IODINE.