IRRIGATION
Received Feb 23, 2026 · Event occurred Dec 17, 2025
Report 2124215-2026-09906 · MDR key 24420864
Device
Generic name
Catheter, Urological
Manufacturer
Boston Scientific CorporationModel number
M0067201000Catalog number
720-100S
Lot number
0037673817
Product problems
- Device Contaminated During Manufacture or Shipping
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A SINGLE ACTION PUMP WAS SET TO BE USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT A HAIR WAS INSIDE THE PACKAGING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A1802 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATTER.
Description of Event or Problem
IT WAS REPORTED THAT A SINGLE ACTION PUMP WAS SET TO BE USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT A HAIR WAS INSIDE THE PACKAGING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A1802 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATTER. BLOCK H11: INVESTIGATION RESULTS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS THEREFORE TECHNICAL ANALYSIS COULD NOT BE PERFORMED; HOWEVER, MEDIA ANALYSIS SHOWS THAT THE PART OF ONE POUCH WITH A FOREIGN MATTER. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF WAS CONFIRMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. BASED ON THE INVESTIGATION RESULTS, THE REPORTED PROBLEM RELATED TO THE PRESENCE OF FOREIGN MATERIAL WAS CONSIDERED CONFIRMED. HOWEVER, THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE RETURN OF THE DEVICE WOULD BE NECESSARY TO VERIFY THE CONDITION OF THE POUCH AND TO DETERMINE THE EXACT LOCATION OF THE REPORTED FOREIGN MATERIAL WITHIN THE PRODUCT OR PACKAGING. WITHOUT THE PHYSICAL DEVICE AVAILABLE FOR FURTHER ANALYSIS, IT IS NOT POSSIBLE TO PERFORM A DETAILED INSPECTION TO DETERMINE WHETHER THE FOREIGN MATERIAL ORIGINATED FROM THE DEVICE, PACKAGING, OR ANOTHER EXTERNAL SOURCE. ALTHOUGH THE REPORTED EVENT IS CONSIDERED CONFIRMED BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION CANNOT TRACE THE CAUSE MORE SPECIFICALLY. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION AN INVESTIGATION CONCLUSION CODE OF CAUSE LINKED TO DEVICE BUT UNABLE TO TRACE MORE SPECIFICALLY WAS ASSIGNED TO THIS INVESTIGATION.