inforMED — FDA medical device performance lookup

Device

Generic name

Endoscopic Cytology Brush

Manufacturer

Boston Scientific Corporation

Model number

M00545000

Catalog number

M00545000

Lot number

0035645871

Product problems

Detachment 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

Patient

54 YR · Male

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or 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. ***ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 04, 2025*** THE BRUSH TIP WAS FRACTURED INTO TWO SEPARATE PARTS.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BRUSH TIP FRACTURED. BLOCK H11: INVESTIGATION RESULTS THE RETURNED RX CYTOLOGY BRUSH WAS RECEIVED FOR ANALYSIS. A VISUAL EXAMINATION REVEALED DAMAGE ALONG THE WORKING LENGTH, WITH MULTIPLE KINKS OBSERVED IN SEVERAL AREAS, INCLUDING KINKING OF THE WIRE. DUE TO THIS DAMAGE, EXTENSION OF THE BRUSH COULD NOT BE PERFORMED DURING FUNCTIONAL TESTING. THE DISTAL BRUSH END WAS OBSERVED TO BE INTACT, WITH NO EVIDENCE OF DETACHMENT OR DAMAGE. THE REPORTED EVENT COULD NOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE OBSERVED DAMAGE IS MOST LIKELY ATTRIBUTABLE TO PROCEDURAL FACTORS, SUCH AS DEVICE HANDLING AND THE TECHNIQUE USED BY THE PHYSICIAN, INCLUDING THE APPLICATION OF FORCE DURING USE. A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATE THAT THE MOST PROBABLE ROOT CAUSE FOR THE DAMAGE OBSERVED DURING ANALYSIS IS ADVERSE EVENT RELATED TO PROCEDURE. THE REPORTED EVENT OF BRUSH DETACHMENT IS CLASSIFIED AS NO PROBLEM DETECTED, AS THE BRUSH WAS NOT DETACHED OR DAMAGED.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BRUSH TIP FRACTURED.

Description of Event or 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.

Additional Manufacturer Narrative

BLOCK H2: BLOCK B5 HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 04, 2025. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BRUSH TIP FRACTURED.

Description of Event or 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 SEPTEMBER 25, 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. ***ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 04, 2025*** THE BRUSH TIP WAS FRACTURED INTO TWO SEPARATE PARTS.