NephroMax M0062101170Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729012641), received between Jun 16, 2017 and Apr 20, 2026 — classified as 4 injuries, 28 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTRIPSY (PNL) PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THERE WAS A TINY HOLE IN THE BALLOON PART, SO IT DOES NOT EXPAND. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933158 ↗
• MalfunctionMar 30, 2026Burst Container or Vessel; Material Deformation

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE BLUE SHEATH HAD A DENT. ADDITIONALLY, THE BALLOON WOULD NOT INFLATE AT 18 ATMOSPHERE (ATM). REPORTEDLY, UPON PULLING OUT THE BALLOON TO REINFLATE IT POPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715390 ↗
• MalfunctionMar 16, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE AND FOUND THAT IT HAD A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613370 ↗
• MalfunctionSep 17, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. REPORTEDLY, WHEN THEY WERE BLOWING UP THE BALLOON IT POPPED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077619 ↗
• MalfunctionFeb 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS ABOUT TO BE USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL). DURING PREPARATION, IT WAS FOUND THAT THE BALLOON WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356535 ↗
• MalfunctionJul 1, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED BELOW 20 ATMOSPHERES (ATM); HOWEVER, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC FACIAL DILATOR WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652083 ↗
• MalfunctionMay 27, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED A NEPHROMAX BALLOON CATHETER AND PUMPED SALINE WITH AN ENCORE HIGH PRESSURE INFLATION AT 12 ATM; HOWEVER, THE BALLOON RUPTURED AND LEAKED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400886 ↗
• MalfunctionNov 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE NEPHROMAX BALLOON WAS TORN AS SOON AS IT WAS INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX NEPHROSTOMY BALLOON CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204793 ↗
• MalfunctionAug 14, 2023Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE BALLOON CONTINUES TO "WASTE" AND WOULD NOT FULLY INFLATE EVEN WHEN INFLATED TO THE MAXIMUM PRESSURE. THE BALLOON WAS REMOVED AND WAS ATTEMPTED TO INFLATE AGAIN MULTIPLE TIMES AFTER SLIGHTLY REPOSITIONING THE WIRE BUT SILL UNSUCCESSFUL. AFTER INSPECTION, IT WAS NOTICED THAT THERE WAS A KINK IN THE BALLOON WHICH WAS CAUSING THE BALLOON FROM FULLY INFLATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX NEPHROSTOMY BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546135 ↗
• MalfunctionNov 10, 2022Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALLOON CATHETER WAS USED IN THE RIGHT KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE ABOVE 8 ATM. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15769888 ↗
• InjuryJun 13, 2022Material Separation; Difficult to Open or Remove Packaging Material; Material Separation; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(4) 2022. IT WAS REPORTED THAT THE BALLOON PROTECTIVE SLEEVE WAS NOT REMOVED FROM THE DEVICE PRIOR TO USE. ULTIMATELY, THE BALLOON PROTECTIVE SLEEVE DETACHED INSIDE THE PATIENT AND WAS RETAINED AFTER A PROCEDURE. A PERCUTANEOUS NEPHROLITHONOMY (PCNL) SURGERY WAS PERFORMED TO RETRIEVE THE DETACHED SLEEVE. THE PROCEDURE WAS COMPLETED AT THIS TIME. NOTE: A PHOTO SUBMITTED BY THE CUSTOMER SHOWS TWO BALLOON PROTECTIVE SLEEVES OUTSIDE PATIENT AND IT COULD BE OBSERVED THAT ONE OF THE BALLOON PROTECTIVE SLEEVES HAD RESIDUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT IS EXPECTED TO FULLY RECOVER. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674156 ↗
• MalfunctionDec 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTRIPSY (PNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS TORN AND WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX NEPHROSTOMY BALLOON CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE PHOTOS SUBMITTED BY THE CUSTOMER CONFIRMED THE TORN ON THE DISTAL SECTION OF THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915606 ↗
• MalfunctionSep 28, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER WAS BEING USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON POPPED AT 20 ATM WHEN INFLATED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544524 ↗
• MalfunctionSep 7, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX NEPHROSTOMY CATHETER BALLOON WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO INFLATE THE BALLOON, THE MIDDLE PORTION OF THE BALLOON WOULD NOT FULLY INFLATE. IT WAS ALSO NOTICED THAT THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX NEPHROSTOMY CATHETER BALLOON. THE PHOTOS SUBMITTED BY THE CUSTOMER CONFIRMED THE BALLOON IRREGULAR SHAPE AND CATHETER KINKED. 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432539 ↗
• MalfunctionSep 22, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER WAS USED IN THE RIGHT KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE PERFORMED IN THE COLON ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, IT WAS NOTICED THAT THE DISTAL TIP OF THE BALLOON CATHETER WAS TWISTED WHEN PREPARING THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION 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 GOOD. **CORRECTION** IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE PERFORMED IN THE RIGHT KIDNEY ON (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10570576 ↗
• MalfunctionSep 18, 2020Burst Container or Vessel; Appropriate Device Problem Term/Code Not Available; Burst Container or Vessel; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHEN INFLATED TO 16 PSI. SUBSEQUENTLY, THE INFLATION MEDIUM OF THE BALLOON WAS FOUND FILLING THE RETROPERITONEUM OF THE PATIENT WHICH MADE THE IMAGE OF THE KIDNEY UNDER FLUOROSCOPY TOO CHALLENGING TO SEE. REPORTEDLY, THERE ARE TWO WIRES IN THE KIDNEY AT THAT TIME. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, AND THE PATIENT HAD TO BE BROUGHT BACK TO THE HOSPITAL AT A LATER DATE FOR ANOTHER PROCEDURE. 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. ADDITIONAL INFORMATION RECEIVED ON 23OCT2020. NOTE: THIS REPORT PERTAINS TO AN ENCORE INFLATION DEVICE AND A NEPHROMAX DILATATION BALLOON CATHETER USED IN THE SAME PATIENT AND PROCEDURE. THE NEPHROMAX DILATATION BALLOON CATHETER WAS USED TOGETHER WITH AND ENCORE INFLATION DEVICE. REPORTEDLY, THE ENCORE INFLATION DEVICE WAS NOTED HARD TO USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10552980 ↗
• MalfunctionJul 8, 2020Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. REPORTEDLY, THE SHEATH GOT STUCK IN THE TISSUE BUT WAS EVENTUALLY TAKEN OUT WITHOUT EXTRA BLEEDING. THE PROCEDURE WAS COMPLETED A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN 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: Hemorrhage/Blood Loss/Bleeding; No Known Impact Or Consequence To Patient

  MAUDE report 10245885 ↗
• MalfunctionJul 8, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON POPPED WHILE BEING INFLATED TO 20 ATM. REPORTEDLY, IT WAS SUSPECTED THAT THE BALLOON WAS OVERFILLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10245881 ↗
• MalfunctionOct 9, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER KIT WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BALLOON WAS NOTED TO HAVE THIN HOLES WHEN INFLATED PRIOR TO PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION BALLOON CATHETER KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9172655 ↗
• MalfunctionOct 3, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON WAS USED DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON SPLIT INSIDE THE PATIENT. REPORTEDLY, THE WHOLE BALLOON WAS INSTANTLY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9150182 ↗
• MalfunctionAug 29, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE WAS PERFORMED IN THE RIGHT KIDNEY ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST WHEN INFLATED BELOW THE LIMIT PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946109 ↗
• MalfunctionJul 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER WAS USED IN THE RIGHT KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ACCESS SHEATH BROKE WHEN IT WAS INSERTED OVER THE INFLATED BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON CATHETER. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8815809 ↗
• MalfunctionJul 22, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION BALLOON CATHETER DEVICE WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON POPPED DURING THE INSERTION OF THE BLUE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX DILATATION BALLOON CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811179 ↗
• InjuryMar 20, 2019Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO NEPHROMAX DILATATION CATHETER USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX DILATATION CATHETER WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST UNDER 20 ATM WHICH CAUSED A LOT OF BLEEDING TO THE PATIENT. REPORTEDLY, THE PATIENT STAYED AT THE HOSPITAL FOR ONE WEEK BEFORE BEING DISCHARGED. THE SAME ISSUE OCCURRED WITH THE SECOND NEPHROMAX DILATATION CATHETER. THE PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE WAS CANCELLED. ***ADDITIONAL INFORMATION RECEIVED ON 29APR2019*** IT WAS REPORTED THAT THE DEVICE WAS USED IN THE NEPHROSTOMY TRACT. REPORTEDLY, THE BLEEDING WAS TREATED BY PRESSURE BLOOD TRANSFUSION. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8437579 ↗
• MalfunctionOct 16, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, THE BALLOON BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROMAX BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970391 ↗