PACEL FLOW DIRECTED PACING CATHETER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H2, H3, H6, H11 ONE 5F PACEL (FLOW DIRECT) PACING CATHETER AND ONE 1.25CC LIMITED VOLUME SYRINGE WERE RECEIVED FOR ANALYSIS. THE BALLOON WAS NOTED TO BE TORN AND ROLLED UP FROM THE DISTAL END OF THE BALLOON. NO OTHER VISUAL ANOMALIES WERE NOTED. THE LIMITED VOLUME SYRINGE WAS REMOVED FROM THE DEVICE, THE PLUNGER WAS RETRACTED TO THE 1.25CC LINE THEN THE RETURNED SYRINGE WAS REATTACHED TO THE STOPCOCK BEFORE TESTING. THE ENTIRE CATHETER SUBMERSED IN A WATER BATH AT 37º CELSIUS FOR TWO MINUTES. THE SYRINGE PLUNGER WAS THEN DEPRESSED; THE BALLOON DID NOT INFLATE. THE SYRINGE WAS THEN REMOVED AND PULLED BACK AND REATTACHED TO THE CATHETER AGAIN, THE CATHETER WAS THEN SUBMERSED IN WATER. THE SYRINGE PLUNGER WAS THEN DEPRESSED A SECOND TIME AND THE BALLOON DID NOT INFLATE. MICROSCOPIC INSPECTION CONFIRMED A TEAR AT THE DISTAL END OF THE BALLOON. THE BALLOON ADHESIVE APPEARED INTACT. THE RESULTS OF THE INVESTIGATION CONFIRMED A TEAR AT THE DISTAL END OF THE BALLOON. THE BALLOON WAS UNABLE TO INFLATE DUE TO A LEAK AT THE TEAR LOCATION. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE INFLATION ISSUE AND TEAR REMAINS UNKNOWN.

Description of Event or Problem

DURING THE PROCEDURE, THE BALLOON WAS PROPERLY DEFLATED, BUT DURING REMOVAL, IT WAS FOUND THAT THE BALLOON WAS CRACKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.