FDA Adverse Event
Malfunction
Summary report: N
CRE WIREGUIDED
MDR report key: 24423814
·
Received February 23, 2026
Report
- Report Number
- 3005099803-2026-00690
- Event Type
- Malfunction
- Date Received
- February 23, 2026
- Date of Event
- January 26, 2026
- Report Date
- February 23, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FDF
- UDI-DI
- 08714729339427
- PMA / PMN Number
- K110833
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A020504 CAPTURES THE REPORTABLE EVENT OF HOLE IN THE DEVICE PACKAGING.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT CRE WIREGUIDED DILATATION BALLOON WAS INSPECTED AT THE HEALTHCARE FACILITY ON JANUARY 26, 2026. DURING THE INSPECTION, IT WAS REPORTED THAT THERE WAS A HOLE IN THE DEVICE PACKAGING AND COMPROMISED THE STERILE BARRIER. THERE WERE NO PATIENT INVOLVED IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474158 | CRE WIREGUIDED | COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FDF | BOSTON SCIENTIFIC CORPORATION | M00558490 | 0038200167 | 08714729339427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |