FDA Adverse Event
Malfunction
Summary report: N
CRE FIXED WIRE
MDR report key: 23121662
·
Received September 23, 2025
Report
- Report Number
- 3005099803-2025-04759
- Event Type
- Malfunction
- Date Received
- September 23, 2025
- Date of Event
- August 1, 2025
- Report Date
- September 23, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNQ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON WOULD NOT DEFLATE.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED IN AN UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN REPORTED A BALLOON DEFLATION PROBLEM AND REMOVING THE BALLOON THROUGH THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 734541 | CRE FIXED WIRE | DILATOR, ESOPHAGEAL | KNQ | BOSTON SCIENTIFIC CORPORATION | M00558370 | 0036893738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |