UROMAX ULTRA

Additional Manufacturer Narrative

BLOCK H2: ADDITIONAL INFORMATION: BLOCK A2, BLOCK B3, BLOCK B5 AND BLOCK D7A. BLOCKS D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: DEVICE CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON WOULD NOT DEFLATE. BLOCK H11: INVESTIGATION RESULTS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, COMPLAINT EVENT IS NOT CONFIRMED SINCE IT DID NOT INCLUDE A RETURNED DEVICE OR MEDIA REVIEW TO IDENTIFY ANY PROBLEM THAT CONFIRMS THE REPORTED ALLEGATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. ADDITIONALLY, WITHOUT PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN THE MOST PROBABLE CAUSE THAT CONTRIBUTED TO THE EVENT. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. REPORTEDLY, THE BALLOON DEVICE WAS INFLATED AS INTENDED; HOWEVER, IT DID NOT DEFLATE. THE DEVICE WAS WITHDRAWN WHILE STILL IN AN EXPANDED STATE WITHIN THE URETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

Additional Manufacturer Narrative

BLOCKS D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: DEVICE CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON WOULD NOT DEFLATE. BLOCK H11: INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, COMPLAINT EVENT IS NOT CONFIRMED SINCE IT DID NOT INCLUDE A RETURNED DEVICE OR MEDIA REVIEW TO IDENTIFY ANY PROBLEM THAT CONFIRMS THE REPORTED ALLEGATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. ADDITIONALLY, WITHOUT PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN THE MOST PROBABLE CAUSE THAT CONTRIBUTED TO THE EVENT. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED IN A PROCEDURE. REPORTEDLY, THE BALLOON DEVICE WAS INFLATED AS INTENDED; HOWEVER, IT DID NOT DEFLATE. THE DEVICE WAS WITHDRAWN WHILE STILL IN AN EXPANDED STATE WITHIN THE URETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.