TRANSVENOUS PACING ELECTRODES, BIPOLAR BALLOON TPE CATHETER

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING AS IT STATES: WARNINGS: ¿ DO NOT INFLATE BALLOON BEYOND STATED MAXIMUM INFLATION CAPACITY OF 1.5 ML. ¿ BALLOON MUST BE COMPLETELY DEFLATED BEFORE WITHDRAWAL OF THE ELECTRODE CATHETER. ¿ IF THE BALLOON CATHETER HAS BEEN INFLATED IN VIVO FOR MORE THAN ONE MINUTE, COMPLETELY DEFLATE THE BALLOON AND REINFLATE IT TO THE RECOMMENDED CAPACITY OF 1.5 ML. THIS IS RECOMMENDED BECAUSE CARBON DIOXIDE DIFFUSES THROUGH THE LATEX BALLOON. PRECAUTION: WHEN USING A BALLOON CATHETER, USE CARE WHEN REMOVING THE PROTECTIVE SLEEVE FROM THE DISTAL PORTION OF THE CATHETER. FORCED REMOVAL OF THIS PROTECTIVE SLEEVE MAY RESULT IN DAMAGE TO THE BALLOON AND THE CATHETERS STRUCTURAL INTEGRITY. INSTRUCTIONS FOR USE: INSPECTION INSTRUCTIONS: 1. INSPECT THE STERILE PACKAGE CAREFULLY FOR DAMAGE DURING TRANSIT OR STORAGE. DO NOT USE THE CATHETER IF THE PACKAGE IS DAMAGED. 2.VISUALLY INSPECT THE CATHETER, UNDER STERILE CONDITIONS, FOR KINKS IN THE CATHETER SHAFT, INTEGRITY OF THE CONNECTOR, CONDITION OF ELECTRODES, AND ANY OTHER DAMAGE. 3.IN CASE OF CATHETERS WITH A BALLOON, UNDER STERILE CONDITIONS, REMOVE THE PROTECTIVE SHEATH AND INFLATE THE BALLOON WITH 1.5 ML OF AIR OR CARBON DIOXIDE. USE THE INFLATION SYRINGE INCLUDED IN THE PACKAGE. COMPLETELY DEFLATE THE BALLOON AFTER THE TEST. INSERTION INSTRUCTIONS USING A NEEDLE CANNULA: 1. OPEN THE PACKAGE AND PLACE THE CONTENTS ON A STERILE FIELD. 2. PREP THE SKIN AT THE SITE OF INSERTION AND INJECT A LOCAL ANESTHETIC. 3. REMOVE THE PROTECTIVE GUARD FROM THE NEEDLE CANNULA. 4. ENTER THE VEIN WITH THE NEEDLE CANNULA. SIMULTANEOUS ASPIRATION INTO A SYRINGE WILL HELP CONFIRM VESSEL ENTRY. 5. REMOVE THE SYRINGE AND THE NEEDLE. 6. IF USING AN OPEN LUMEN CATHETER, FLUSH THE CATHETER WITH A HEPARINIZED SOLUTION. REMOVE ANY STYLETTE PRIOR TO INSERTION. 7. USING THE AID OF FLUOROSCOPY OR AN ECG MONITOR, ADVANCE THE CATHETER THROUGH THE CANNULA TO THE DESIRED POSITION. IF USING A BALLOON CATHETER, INFLATE THE BALLOON WHEN THE CATHETER IS IN THE RIGHT ATRIUM. PLEASE NOTE THAT THE BALLOON CAN BE INFLATED OR DEFLATED ONLY WHEN THE STOPCOCK IS PARALLEL TO THE CATHETER SHAFT. DO NOT PULL THE CATHETER BACK THROUGH THE CANNULA AS IT MAY CAUSE DAMAGE TO THE CATHETER. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTIONS: D, E. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED BY THE REGISTERED NURSE, MANAGER OF THE INTENSIVE CARE UNIT. FOR THE PACING KIT. INSIDE THE KIT THERE WAS A PACING ELECTRODE CATHETER. WHEN GOING TO INSERT, PROVIDER TESTED BALLOON WHICH WOULD NOT INFLATE. SECOND KIT HAD TO BE OPENED. NOTED THE EXPIRATION DATE FOR NONFUNCTIONING KIT WAS 30 NOV 2025. NEW KIT HAD DIFFERENT LOT AND EXPIRATION. THEY HAVE SUBMITTED A PREVIOUS PRODUCT CONCERN FOR SAME ISSUE. UNCLEAR IF THIS WAS A LARGER SCALE PROBLEM.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED BY THE REGISTERED NURSE, MANAGER INTENSIVE CARE UNIT AT SWEDISH FIRST HILL MEDICAL CENTER, SEATTLE WA, FOR THE PACING KIT. INSIDE THE KIT THERE WAS A PACING ELECTRODE CATHETER. WHEN GOING TO INSERT, PROVIDER TESTED BALLOON WHICH WOULD NOT INFLATE. SECOND KIT HAD TO BE OPENED. NOTED THE EXPIRATION DATE FOR NONFUNCTIONING KIT WAS (B)(6) 2025. NEW KIT HAD DIFFERENT LOT AND EXPIRATION. THEY HAVE SUBMITTED A PREVIOUS PRODUCT CONCERN FOR SAME ISSUE. UNCLEAR IF THIS WAS A LARGER SCALE PROBLEM.