Passport M0062181100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729191872), received between Jul 16, 2018 and Jan 14, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2022Material Puncture/Hole; Material Twisted/Bent; Material Puncture/Hole; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON HAD A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE PHOTOS SUBMITTED BY THE CUSTOMER SHOWS THE BALLOON OUTSIDE THE PATIENT AND IT WAS OBSERVED THAT THE DISTAL TIP OF THE CATHETER WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13259232 ↗
• MalfunctionDec 8, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE CONTRAST AGENT CONTINUED TO DRAIN OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. NOTE: A PHOTO WAS SUBMITTED BY THE CUSTOMER SHOWING A DEFLATED BALLOON. NO VISIBLE PROBLEM WAS NOTED TO THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962237 ↗
• MalfunctionJun 11, 2021Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED IN THE URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS NOT INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. 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. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11981939 ↗
• MalfunctionDec 14, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED IN THE URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ATTEMPTING TO INFLATE THE BALLOON TO 7 ATM, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11002319 ↗
• MalfunctionMay 21, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT DILATATION BALLOON CATHETER DEVICE WAS USED IN THE LEFT URETER DURING A UTEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST UNDER 8.5 ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT 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 10078399 ↗
• MalfunctionApr 10, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A PASSPORT DILATION BALLOON CATHETER DEVICE WAS USED IN THE LEFT URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON INFLATED UNDER 8ATM; HOWEVER, IT EXPLODED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT DILATION BALLOON CATHETER DEVICE. 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 9947758 ↗
• MalfunctionJun 20, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED IN THE RIGHT URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATION 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 8716228 ↗
• MalfunctionJun 20, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT DILATATION BALLOON WAS USED IN THE URETER DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8716210 ↗
• MalfunctionMay 21, 2019Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PASSPORT BALLOON DILATATION CATHETERS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO PASSPORT BALLOON DILATATION CATHETER DEVICES WERE USED IN THE URETER DUING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE SAME ISSUE OCCURED ON THE SECOND PASSPORT BALLOON DILATATION CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8627571 ↗
• MalfunctionMay 21, 2019Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PASSPORT BALLOON DILATATION CATHETERS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO PASSPORT BALLOON DILATATION CATHETER DEVICES WERE USED IN THE URETER DUING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE SAME ISSUE OCCURED ON THE SECOND PASSPORT BALLOON DILATATION CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8627570 ↗
• MalfunctionMar 26, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT DILATATION BALLOON CATHETER WAS USED IN THE LEFT URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT DILATATION BALLOON CATHETER . THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453012 ↗
• MalfunctionJan 8, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATION CATHETER WAS USED IN THE UPPER URETER DURING AN UPPER URS PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST INSIDE THE PATIENT. REPORTEDLY, THE TRANSPARENT BALLOON PORTION OF THE DEVICE THAT DETACHED WAS NOT RETRIEVED AND WAS LEFT TO PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8228815 ↗
• MalfunctionDec 13, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED IN THE UPPER URETER DURING AN UPPER URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2018 . ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE. REPORTEDLY, THE DEVICE WAS CUT USING SCISSORS. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. 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 Consequences Or Impact To Patient

  MAUDE report 8160990 ↗
• MalfunctionNov 6, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED DURING AN UPPER URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER . THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8041594 ↗
• MalfunctionJul 16, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED DURING AN UPPER URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, UPON COMPLETION OF THE PROCEDURE, DURING WITHDRAWAL, THE BALLOON WOULD NOT DEFLATE. IT WAS REPORTED THAT THE INFLATION MEDIUM WAS EVENTUALLY REMOVED FROM THE BALLOON. 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 Consequences Or Impact To Patient

  MAUDE report 7691495 ↗