RX Cytology Brush M00545000Recalls & reported problems

Summary

The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 08714729268628), received between Nov 18, 2016 and May 7, 2026 — classified as 7 injuries, 154 malfunctions.

The most frequently reported specific device problem is “Break” (67 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 161 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX CYTOLOGY BRUSH WAS USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON AN UNKNOWN DATE. DURING PREPARATION, WHILE RETRACTING THE BRUSH, THE INTERNAL MECHANISM FAILED, CAUSING THE COMPONENT TO SNAP. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116556 ↗
• MalfunctionOct 20, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE COMMON BILE DUCT DURING A CYTOLOGICAL BRUSH DETECTION OF TUMORS PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE BRUSH TIP WAS FRACTURED AND COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337315 ↗
• MalfunctionMar 10, 2025Detachment of Device or Device Component; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BRUSH PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, AT THE 4TH TIME INSERTING THE BRUSH, IT WAS MORE DIFFICULT AND THERE WAS RESISTANCE NOTED. ON THE 5TH TIME, THE METAL PIN BENT, AND THE BRUSH COULD NO LONGER FIT INTO THE SHEATH. THE BRUSH WAS SENT FOR PATHOLOGY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BRUSH DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562495 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING RX CYTOLOGY BRUSHES THROUGH THE ARTICLE, COMPARISON OF TWO INTRADUCTAL BRUSH CYTOLOGY DEVICES FOR SUSPECTED MALIGNANT BILIARY STRICTURES: RANDOMIZED CONTROLLED TRIAL, BY MYRTE GORRIS, ET AL. PER THE ARTICLE, BETWEEN JUNE 2016 AND JUNE 2021, RX CYTOLOGY BRUSHES WERE USED IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES DURING A RANDOMIZED CONTROLLED TRIAL. PROCEDURE-RELATED ADVERSE EVENTS MENTIONED IN THE ARTICLE INCLUDED PANCREATITIS, GASTRO-INTESTINAL BLEEDING, CHOLANGITIS, CHOLECYSTITIS, AND POST-PROCEDURAL PAIN. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

  Patient problems: Cholangitis; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Pancreatitis

  MAUDE report 21425843 ↗
• MalfunctionJan 10, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THERE WERE KINKED MARKS ON THE SHAFT AND THE BRUSH TIP HAD DETACHED. ANOTHER RX CYTOLOGY BRUSH WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126911 ↗
• MalfunctionMay 1, 2024Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE BRUSH COULD NOT EXTEND OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF THE BRUSH DETACHED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220788 ↗
• MalfunctionMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2024. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE BRISTLES OF THE BRUSH WERE BROKEN/MISSING. THE PROCEDURE WAS COMPLETED USING ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957076 ↗
• MalfunctionMar 12, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE COMMON BILE DUCT DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WIRE IN THE SHEATH WAS DAMAGED/DEFECTIVE. IT WAS ALSO REPORTED THAT THE HANDLE WAS DIFFICULT TO OPERATE, AND AN UNUSUAL NOISE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE MALFUNCTION OF THE DEVICE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18883261 ↗
• MalfunctionFeb 28, 2024Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE WIRE CONNECTED TO THE HANDLE SUDDENLY BROKE. ANOTHER RX CYTOLOGY BRUSH WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803657 ↗
• MalfunctionDec 14, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2023. DURING THE PROCEDURE, THE TIP OF THE BILIARY BRUSH WAS DAMAGED AND HAD A GAP WHILE THE PATIENT WAS BEING TREATED FOR UPPER ABDOMINAL DISCOMFORT. HOWEVER, THE TIP WAS NOT DETACHED AND DID NOT FALL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333141 ↗
• MalfunctionOct 3, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE STOMACH DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND BILIARY BRUSH EXAMINATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BLUE CAP AT THE END OF THE CYTOLOGY BRUSH DELIVERY DEVICE COULD NOT RETURN TO ITS ORIGINAL POSITION AFTER IT WAS PUSHED OUT, AND THE TIP OF THE BILIARY BRUSH WAS DAMAGED AND HAD A GAP. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860576 ↗
• MalfunctionApr 12, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 2.1MM WIREGUIDED RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE BRISTLED PART OF THE DEVICE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16722994 ↗
• MalfunctionMar 9, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE TIP OF THE BRUSH WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512172 ↗
• MalfunctionMar 6, 2023Break; Mechanical Problem; Detachment of Device or Device Component; Break; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BRUSH EXTENDED AND RETRACTED DURING TESTING; HOWEVER, WHEN THE TECHNICIAN TRIED TO EXTEND THE BRUSH AGAIN, IT WAS STUCK INSIDE THE WORKING LENGTH AND DID NOT EXTEND. IT WAS ALSO NOTED THAT THE WORKING LENGTH DETACHED, AND THE WIRE WITHIN THE CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483640 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE DUODENUM/BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE EXPOSED WIRE NEAR THE BRUSH PORTION WAS BROKEN BUT IT WAS NOT COMPLETELY DETACHED. ADDITIONALLY, THE WIRE WITHIN THE HANDLE WAS ALSO BROKEN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592937 ↗
• MalfunctionOct 12, 2022Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED FOR EPIGASTRIC DISCOMFORT IN THE STOMACH DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE AND BILIARY BRUSH EXAMINATION PERFORMED ON (B)(6) 2022. WHEN THE PHYSICIAN EXAMINED THE MEDICAL DEVICES BEFORE PROCEDURE, THE TIP WAS DAMAGED AND NOTCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15590070 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX CYTOLOGY BRUSH WAS USED FOR CHOLANGIOCARCINOMA IN THE COMMON BILE DUCT DURING A ENDOSCOPIC PANCREATO-CHOLANGIOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE WIRE OF THE BRUSH WAS FOUND TO BE SEPARATED BEFORE USAGE SO IT WAS UNABLE TO USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15435119 ↗
• MalfunctionJun 24, 2022Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE BILIARY DURING A BILIARY TISSUE SAMPLING PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE BRISTLED PORTION OF THE BRUSH WAS BENT. THE DEVICE WAS IN A TORTUOUS POSITION WHEN THE PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. 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 BRUSH DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14807125 ↗
• MalfunctionMay 27, 2022Mechanical Problem; Use of Device Problem; Material Twisted/Bent; Mechanical Problem; Use of Device Problem; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BRUSH DID NOT RELEASE OUT OF THE CATHETER AND HANDLE WAS KINKED DUE TO PRESSURE APPLIED. THE PROCEDURE WAS ABORTED BUT THE PATIENT WAS SEDATED. THE REASON FOR THE ABORTED PROCEDURE IS THERE WAS NO POSSIBILITY TO ACQUIRE CELLS DUE TO UNFUNCTIONAL BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14523425 ↗
• MalfunctionApr 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BRUSH PORTION WITH THE SHEATH DETACHED INSIDE THE PATIENT'S BODY. A RAT TOOTH FORCEPS WAS USED TO REMOVE THE DETACHED PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116207 ↗
• MalfunctionJan 18, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS PREPARED FOR USE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ENDOSCOPIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION AND OUTSIDE THE PATIENT, THE BRUSH DID NOT EXTEND AND IT WAS REPORTED THAT THE PATIENT WAS SEDATED WHEN THE EVENT OCCURRED. IT WAS ALSO REPORTED THAT THE PATIENT COULD NOT ACCEPT THE PROLONGED PROCEDURE WHICH RESULTED IN CANCELLATION OF THE 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13281742 ↗
• MalfunctionJan 14, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS PREPARED FOR USE IN THE BILE DUCT DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ENDOSCOPIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING PREPARATION AND OUTSIDE THE PATIENT, THE BRUSH FAILED TO EXTEND AFTER OPENING THE PACKAGE AND THE HANDLE COULD NOT BE PUSHED. THE PHYSICIAN DID NOT TRY TO FULLY EXTEND THE DEVICE BEFORE USE. NO KINKS WERE NOTED ALONG THE WORKING LENGTH. NO VISUAL DAMAGE WAS NOTED IN THE HANDLE. THE PROCEDURE WAS DISCONTINUED AND THE TARGET TREATMENT WAS NOT COMPLETED. HOWEVER, THE PHYSICIAN DID NOT INFORM ON PLANNING TO COMPLETE THE PROCEDURE SINCE HE ESTIMATED THAT THE PATIENT MAY NOT ENDURE PROLONGED PROCEDURE ALTHOUGH THE PATIENT HAS NO COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13260486 ↗
• MalfunctionJan 14, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS PREPARED FOR USE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION AND OUTSIDE THE PATIENT, THE BRUSH DID NOT EXTEND AND IT WAS REPORTED THAT THE PATIENT WAS SEDATED WHEN THE EVENT OCCURRED. IT WAS ALSO REPORTED THAT THE PATIENT COULD NOT ACCEPT THE PROLONGED PROCEDURE WHICH RESULTED IN CANCELLATION OF THE 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13259327 ↗
• MalfunctionNov 4, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX CYTOLOGY BRUSH WAS USED TO DIAGNOSE A SUSPECTED BILE DUCT CANCER IN THE COMMON BILE DUCT DURING A SPECIMEN COLLECTION PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SHEATH AND WIRE IN THE AREA NEAR THE HANDLE WAS SEPARATED AND THEY WERE UNABLE TO USE THE DEVICE. THE DEVICE WAS NOT IN A TORTUOUS POSITION WHEN THE PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751944 ↗
• MalfunctionOct 22, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE UNITS OF RX CYTOLOGY BRUSH DEVICES WERE ORDERED ON AUGUST 19TH AND ARRIVED ON AUGUST 20TH. ON (B)(6) 2021, IT WAS DISCOVERED THAT THE SEAL OF ONE OF THE DEVICES WAS PEELED OFF AND THE STERILE POUCH WAS COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12684538 ↗