PRUITT AORTIC OCCLUSION CATHETER

Additional Manufacturer Narrative

WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. WE OBSERVED THE TYVEK LID WAS COMPLETELY SEALED TO THE PRODUCT TRAY. THE SEAL MARKS ON THE FLANGES OF THE TRAYS WERE COMPLETE AND UNIFORM CONFIRMING THAT THE TRAYS WERE PROPERLY SEALED DURING OUR PACKAGING PROCESS. THE DEVICES WERE RETURNED TO US WITHOUT THE FOIL POUCH. EVEN BEFORE OPENING THE PACKAGE, WE CAN SEE THE BALLOON OF THIS CATHETER WAS DAMAGED DUE TO DEGRADATION. THIS COMPLAINT UNIT WAS SOLD TO THIS HOSPITAL MORE THAN 3 YEARS AGO. SINCE NATURAL RUBBER LATEX IS AFFECTED BY ENVIRONMENTAL CONDITIONS, THESE CATHETERS ARE PACKAGED IN THE FOIL POUCH TO ACHIEVE OPTIMUM SHELF LIFE. THE PRODUCTS SHOULD BE STORED IN ALUMINUM FOIL POUCHES THAT HELP TO PREVENT THE BALLOONS FROM PREMATURE DETERIORATION. THESE POUCHES SHOULD ONLY BE REMOVED IMMEDIATELY PRIOR TO USE. WE HAVE REQUESTED THE CUSTOMER TO PROVIDE US WITH INFORMATION ON HOW THESE CATHETERS WERE STORED AT THE HOSPITAL. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT NUMBER. THEREFORE, WE BELIEVE THAT IT WAS AN ISOLATED INCIDENT. THE MALFUNCTION WAS DETECTED DURING THE PRE-USE CHECK. THE SURGEON USED ANOTHER CATHETER TO COMPLETE THE PROCEDURE.

Description of Event or Problem

WHEN THE PHYSICIAN OPENED THE PACKAGING, THE BALLOON HAD ALREADY RUPTURED IN THE TRAY. THE SURGEON THEN USED ANOTHER PURITT AORTIC OCCLUSION CATHETER TO COMPLETE THE PROCEDURE.