CRE PRO GI
Report
- Report Number
- 3005099803-2025-02528
- Event Type
- Malfunction
- Date Received
- June 4, 2025
- Date of Event
- May 9, 2025
- Report Date
- August 28, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNQ
- UDI-DI
- 08714729933908
- PMA / PMN Number
- K971320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF BALLOON TIP BENT.
BLOCK H2 (ADDITIONAL INFORMATION): BLOCK E1 (INITIAL REPORTER FIRST NAME) HAS BEEN UPDATED. BLOCK H6: IMDRF DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF BALLOON TIP BENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO GI WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CATHETER TIP WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO GI WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO GI WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CATHETER TIP WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO GI WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 761902 | CRE PRO GI | DILATOR, ESOPHAGEAL | KNQ | BOSTON SCIENTIFIC CORPORATION | M00558790 | 0035526250 | 08714729933908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |