ACCORDING TO THE INITIAL REPORTER, FOUR INCIDENTS WHERE IT WAS IMPOSSIBLE TO IMPLANT/USE THE PRODUCT REGARDING THE PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET DURING A PROCEDURE ON A SINGLE PATIENT. THE USER HAD EXPERIENCED DIFFICULTY ADVANCING THROUGH THE KIDNEYS. AT THIS TIME, IT IS UNCLEAR IF ANY OF THESE INCIDENTS MAY HAVE LED TO REPEATED RENAL PUNCTURES, RISKS OF KIDNEY BRUISES, INABILITY TO IMPLANT DURING EMERGENCY SITUATIONS AND OTHER UNKNOWN ISSUES. SINCE THE REPORTER HAS NOT INDICATED WHICH OF THE FOUR DEVICES MAY HAVE CAUSED THE ADVERSE EVENTS, IT WAS DETERMINED TO REPORT ON THIS EVENT AS A SIDE OF CAUTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
N
Patient 1
(B)(4). AT THIS TIME IT IS UNCLEAR IF ANY OF THESE INCIDENTS MAY HAVE LED TO REPEATED RENAL PUNCTURES, RISK OF KIDNEY BRUISES, INABILITY TO IMPLANT DURING EMERGENCY. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.
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Patient 1
(B)(4). INVESTIGATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, QUALITY CONTROL (QC), SPECIFICATIONS, FUNCTIONAL TESTING AND A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS CONDUCTED FOR THE PURPOSE OF THIS INVESTIGATION. THREE DILATORS (6, 7, AND 8FR) AND A COOK MALECOT CATHETER FROM A PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET WAS RETURNED FOR INVESTIGATION. THE WIRE GUIDE FROM THE SET WAS NOT RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION OF THE DEVICES NOTED THE TIPS OF THE DILATORS APPEARED SPLIT AND STRETCHED. A COOK MEDICAL .038? PTFE WIRE GUIDE WAS PASSED SUCCESSFULLY THROUGH EACH OF THE DILATORS AND THE MALECOT. THE CURRENT CONTROLS IN PLACE FOR MANUFACTURING QC ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO TRANSPORTATION. EACH PACKAGED DEVICE IS SENT WITH INSTRUCTIONS FOR USE. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MADE TO SPECIFICATION. IT IS LIKELY THAT THE PHYSICIAN WAS UNABLE TO GAIN ADEQUATE ACCESS OF THE KIDNEY WITH THE GUIDE WIRE, HOWEVER, WITH THE INFORMATION PROVIDED A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.
D
Patient 1
ACCORDING TO THE INITIAL REPORTER, FOUR INCIDENTS OCCURRED WHERE IT WAS IMPOSSIBLE TO IMPLANT/USE THE PRODUCT REGARDING THE PERCUTANEOUS PIGTAIL NEPHROSTOMY ACCESSORY SET DURING A PROCEDURE ON A SINGLE PATIENT. THE USER HAD EXPERIENCED DIFFICULTY ADVANCING THROUGH THE KIDNEYS. AT THIS TIME, IT IS UNCLEAR IF ANY OF THESE INCIDENTS MAY HAVE LED TO REPEATED RENAL PUNCTURES, RISKS OF KIDNEY BRUISES, INABILITY TO IMPLANT DURING EMERGENCY SITUATIONS AND OTHER UNKNOWN ISSUES. SINCE THE REPORTER HAS NOT INDICATED WHICH OF THE FOUR DEVICES MAY HAVE CAUSED THE ADVERSE EVENTS, IT WAS DETERMINED TO REPORT ON THIS EVENT AS A SIDE OF CAUTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.