CRE FIXED WIRE
Report
- Report Number
- 3005099803-2025-03373
- Event Type
- Malfunction
- Date Received
- July 16, 2025
- Date of Event
- June 24, 2025
- Report Date
- November 13, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNQ
- UDI-DI
- 08714729202011
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6: IMDRF DEVICE CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON FAILURE TO DEFLATE.
BLOCK H6: IMDRF DEVICE CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON FAILURE TO DEFLATE. BLOCK H11: INVESTIGATION RESULTS. THE RETURNED CRE FIXED WIRE DILATATION BALLOON WAS ANALYZED AND VISUAL INSPECTION FOUND THAT THE BALLOON WAS DETACHED, PRODUCED BY A MECHANICAL CUT. A FUNCTIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE DEVICE WAS CUT OFF. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF BALLOON FAILURE TO DEFLATE WAS UNABLE TO BE CONFIRMED. THE BALLOON WAS DETACHED; THEREFORE, FUNCTIONALITY COULD NOT BE TESTED. ALSO, EVIDENCE OF A MECHANICAL CUT IN THE CATHETER WAS FOUND DURING ANALYSIS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS CAUSE NOT ESTABLISHED.
BLOCK H6: IMDRF DEVICE CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON FAILURE TO DEFLATE. BLOCK H11: INVESTIGATION RESULTS THE RETURNED CRE FIXED WIRE DILATATION BALLOON WAS ANALYZED AND VISUAL INSPECTION FOUND THAT THE BALLOON WAS DETACHED, PRODUCED BY A MECHANICAL CUT. A FUNCTIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE DEVICE WAS CUT OFF. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF BALLOON FAILURE TO DEFLATE WAS UNABLE TO BE CONFIRMED. THE BALLOON WAS DETACHED; THEREFORE, FUNCTIONALITY COULD NOT BE TESTED. ALSO, EVIDENCE OF A MECHANICAL CUT IN THE CATHETER WAS FOUND DURING ANALYSIS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS CAUSE NOT ESTABLISHED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING WITHDRAWAL, AN ATTEMPT WAS MADE TO DEFLATE AND REMOVE THE BALLOON. HOWEVER, IT COULD NOT BE DEFLATED, AND THE ENTIRE SCOPE HAD TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING WITHDRAWAL, AN ATTEMPT WAS MADE TO DEFLATE AND REMOVE THE BALLOON. HOWEVER, IT COULD NOT BE DEFLATED, AND THE ENTIRE SCOPE HAD TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING WITHDRAWAL, AN ATTEMPT WAS MADE TO DEFLATE AND REMOVE THE BALLOON. HOWEVER, IT COULD NOT BE DEFLATED, AND THE ENTIRE SCOPE HAD TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600962 | CRE FIXED WIRE | DILATOR, ESOPHAGEAL | KNQ | BOSTON SCIENTIFIC CORPORATION | M00558380 | 0035889114 | 08714729202011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |