Occluder M0062201090Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729192008), received between Sep 27, 2018 and Jul 3, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN OCCLUDER BALLOON CATHETER DEVICES WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON; HOWEVER, THE CONTRAST WAS VISIBLY LEAKING OUT ON FLUOROSCOPY. REPORTEDLY, THE OCCLUSION BALLOON DID HAVE A SLIT IN IT WHICH CAUSED CONTRAST TO LEAK OUT AND THE BALLOON COULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FIRST OF TWO OCCLUDER BALLOON CATHETER DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401506 ↗
• MalfunctionJul 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN OCCLUDER BALLOON CATHETER DEVICES WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON; HOWEVER, THE CONTRAST WAS VISIBLY LEAKING OUT ON FLUOROSCOPY. REPORTEDLY, THE OCCLUSION BALLOON DID HAVE A SLIT IN IT WHICH CAUSED CONTRAST TO LEAK OUT AND THE BALLOON COULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE SECOND OF TWO OCCLUDER BALLOON CATHETER DEVICES USED IN THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401503 ↗
• MalfunctionOct 18, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A OCCLUDER BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE INFLATED BALLOON WAS NOT VISIBLE UNDER A FLUOROSCOPY AND SUSPECTED TO HAVE BEEN BURST. HOWEVER, ONCE THEY PROCEED WITH THE PROCEDURE, THEY CHECK THE BALLOON'S CONDITION, AND IT TURNED OUT TO HAVE A HOLE ON IT CAUSING IT TO LEAK HENCE IT GOT DEFLATED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 24, 2023: IT WAS REPORTED THAT A OCCLUDER BALLOON CATHETER WAS USED IN THE KIDNEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957024 ↗
• MalfunctionSep 18, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A TRANSJUGULAR LIVER BIOPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE OCCLUDER BALLOON HAD A FLY INSIDE THE PACKAGING. IT WAS REPORTED THAT THE BOX AND THE STERILE PACKAGING WERE BOTH SEALED WITH NO SIGN OF DAMAGE OR TAMPERING. IT WAS DEEMED CONTAMINATED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765868 ↗
• MalfunctionAug 7, 2023Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO OCCLUDER BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO OCCLUDER BALLOON CATHETERS WERE TO BE USED IN THE URETER AND KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, BOTH BALLOONS WERE LEAKING AND THERE WAS A POSSIBLE TEAR OR HOLE IN THE BALLOON WHEN TESTED PRIOR TO INSERTION. THE PROCEDURE WAS COMPLETED WITHOUT USING AN OCCLUSION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469381 ↗
• MalfunctionAug 7, 2023Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO OCCLUDER BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO OCCLUDER BALLOON CATHETERS WERE TO BE USED IN THE URETER AND KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, BOTH BALLOONS WERE LEAKING AND THERE WAS A POSSIBLE TEAR OR HOLE IN THE BALLOON WHEN TESTED PRIOR TO INSERTION. THE PROCEDURE WAS COMPLETED WITHOUT USING AN OCCLUSION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469169 ↗
• MalfunctionOct 21, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE DEVICE WAS INSERTED IN THE URETER AND THE PHYSICIAN FILLED IN THE BALLOON; HOWEVER, THE BALLOON BURST WHEN INFLATED TO 11 ATM. IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITHOUT USING AN OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT OUTCOME OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649519 ↗
• MalfunctionOct 20, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON WAS ABLE TO BE INFLATED WHEN IT WAS PLACED IN THE PELVIC URETERIC JUNCTION; HOWEVER, THE BALLOON LOOKED DEFLATED AFTER A WHILE, AND DOES NOT LOOK INFLATED UNDER THE X-RAY VIEW. THE DEVICE WAS THEN REMOVED FROM THE PATIENT, AND IT WAS CONFIRMED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638088 ↗
• MalfunctionJan 20, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER DEVICE WAS USED BELOW THE PELVIC URETERIC JUNCTION (PUJ) DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE POSITION OF THE PATIENT WAS CHANGED FROM SUPINE TO PRONE, THE BALLOON WAS CONFIRMED TO BE INFLATED UNDER X-RAY; HOWEVER, IT WAS NOTICED THAT THE CONTRAST WAS LEAKING FROM THE BALLOON A MOMENT AFTER. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND IT WAS FOUND THAT THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306565 ↗
• MalfunctionOct 21, 2021Burst Container or Vessel; Deflation Problem; Inflation Problem; Burst Container or Vessel; Deflation Problem; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A KIDNEY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAVE DEFLATION PROBLEMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12672029 ↗
• MalfunctionOct 21, 2021Burst Container or Vessel; Deflation Problem; Inflation Problem; Burst Container or Vessel; Deflation Problem; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A KIDNEY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAVE DEFLATION PROBLEMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12672007 ↗
• MalfunctionJul 9, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE KINDEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON BURST WHILE INFLATING. REPORTEDLY, THE BALLOON WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12146451 ↗
• MalfunctionOct 1, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE KIDNEY AND URETER DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD BURST; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10612372 ↗
• MalfunctionSep 22, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUSION BALLOON CATHETER WAS USED IN THE URETER DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHEN ATTEMPTED TO BE FILLED TO 1 ML. REPORTEDLY, THE BALLOON WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUSION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10570591 ↗
• MalfunctionAug 28, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUSION BALLOON CATHETER WAS USED IN THE URETEROPELVIC JUNCTION OF THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUSION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10465079 ↗
• MalfunctionMar 3, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS LEAKING DUE TO A HOLE IN THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9779312 ↗
• MalfunctionSep 19, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUSION BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ABLE TO BE INFLATED; HOWEVER, A HOLE WAS NOTICED UPON THE INFLATION. REPORTEDLY, IT LOOKED LIKE THERE WAS A CUT OR A TEAR IN IT. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9086525 ↗
• MalfunctionSep 17, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER DILATATION BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON COULD NOT BE INFLATED DUE TO A HOLE. IT LOOKED LIKE THERE WAS A CUT OR A TEAR IN IT. THE PROCEDURE WAS COMPLETED WITHOUT INFLATING THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9075514 ↗
• MalfunctionMay 7, 2019Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO OCCLUSION BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO OCCLUSION BALLOON CATHETERS WERE USED IN THE URETER DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE SAME ISSUE OCCURRED WITH THE SECOND OCCLUSION BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUSION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. **CORRECTION** IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO OCCLUSION BALLOON CATHETERS WERE USED IN THE URETER DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586323 ↗
• MalfunctionMay 6, 2019Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO OCCLUSION BALLOON CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO OCCLUSION BALLOON CATHETERS WERE USED IN THE URETER DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE SAME ISSUE OCCURRED WITH THE SECOND OCCLUSION BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUSION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. CORRECTION: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO OCCLUSION BALLOON CATHETERS WERE USED IN THE URETER DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8582222 ↗
• MalfunctionApr 4, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLON CATHETER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8483233 ↗
• MalfunctionMar 20, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUSION BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE FILLING UP THE BALLOON, IT POPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUSION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438097 ↗
• MalfunctionSep 27, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WOULD NOT STAY INFLATED. REPORTEDLY, THE BALLOON HAD A PINHOLE. THE PROCEDURE WAS CONTINUED USING THE DEFLATED BALLOON AND THE PROCEDURE WAS COMPLETED AT THIS TIME THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7913978 ↗