BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE. THE CONDITIONS OF THE SAMPLE DID NOT ALLOW FURTHER EVALUATION. EVENT DESCRIPTION: ¿IT WAS REPORTED THAT THEY PRE INFLATED THE BALLOON AND IT DID INFLATE BUT WAS "CROOKED". THEY USED THE PRODUCT ON THE ON THE PATIENT AND THE BALLOON RUPTURED IN THE PATIENT. INQUIRED IF IT CAUSED HARM TO THE PATIENT AND SHE STATED IT DID NOT.¿ SAMPLE EVALUATION RESULTS: THE RETURNED SAMPLE WAS NOT FUNCTIONALLY TESTED DUE TO THE CONDITION OF THE BALLOON. A VISUAL INSPECTION WAS PERFORMED, AND NO SUBSTANTIAL OR OUT OF THE ORDINARY CONDITIONS WERE OBSERVED THAT COULD BE CONCLUSIVELY INFERRED FROM THE CONDITION OF THE BALLOON. THIS IS INCONCLUSIVE AS THE SAMPLE RETURNED COULD NOT BE TESTED FOR THE PRODUCT FAILURE. THIS PRODUCT IS 100% INSPECTED FOR PRODUCT INTEGRITY DURING THE MANUFACTURING PROCESS FOR INFLATED BALLOON DIAMETER, BALLOON SYMMETRY AND FOR ANY VISUAL DEFECTS TO THE BALLOON. INVESTIGATION SUMMARY: THE COMPLAINT SAMPLE DOES EXHIBIT THE FAILURE CONDITION ALLEGED BY THE COMPLAINT. THEREFORE, THE COMPLAINT IS CONFIRMED. IT IS POSSIBLE THAT PATIENT OR PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE ALLEGED EVENT. A REVIEW OF MANUFACTURING DOCUMENTATION COULD NOT BE REVIEWED TO INDICATE IF A MANUFACTURING RELATED CAUSE WAS POSSIBLE FOR THESE EVENTS. DHR WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. CORRECTIONS MADE TO TAB(S) D, F, H. 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 THAT THEY PRE-INFLATED THE BALLOON AND IT DID INFLATE BUT WAS "CROOKED". THEY USED THE PRODUCT ON THE ON THE PATIENT AND THE BALLOON RUPTURED IN THE PATIENT. INQUIRED IF IT CAUSED HARM TO THE PATIENT AND SHE STATED IT DID NOT.

Description of Event or Problem

IT WAS REPORTED THAT THEY PRE-INFLATED THE BALLOON AND IT DID INFLATE BUT WAS "CROOKED". THEY USED THE PRODUCT ON THE ON THE PATIENT AND THE BALLOON RUPTURED IN THE PATIENT. INQUIRED IF IT CAUSED HARM TO THE PATIENT AND SHE STATED IT DID NOT.

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.