CRE PRO GI
Report
- Report Number
- 3005099803-2025-01869
- Event Type
- Malfunction
- Date Received
- May 1, 2025
- Date of Event
- April 8, 2025
- Report Date
- July 15, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNQ
- UDI-DI
- 08714729933885
- PMA / PMN Number
- K971320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF A BALLOON PINHOLE IN THE ESOPHAGUS. H11: THE RETURNED CRE PRO GI WIREGUIDED DILATION BALLOON WAS ANALYZED, AND A VISUAL INSPECTION FOUND THE BALLOON WAS BURST. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF BALLOON PINHOLE WAS UNABLE TO BE CONFIRMED DURING THE PRODUCT INVESTIGATION. BASED ON THE CONDITION OF THE RETURNED DEVICE, IT IS POSSIBLE THAT THE RUPTURE FOUND IN THE BALLOON OCCURRED DUE TO PROCEDURAL FACTORS SUCH AS EXCESS OF PRESSURE, INTERACTION WITH OTHER DEVICES. ALSO, IT IS POSSIBLE THAT INTERACTION WITH A SHARP SURFACE DURING/PREVIOUS PROCEDURE, COULD HAVE CAUSED THE PROBLEM FOUND ON THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.
BLOCK H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF A BALLOON PINHOLE IN THE ESOPHAGUS.
BLOCK H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF A BALLOON PINHOLE IN THE ESOPHAGUS. BLOCK H11: (CORRECTION). THE RETURNED CRE PRO GI WIREGUIDED DILATION BALLOON WAS ANALYZED, AND A VISUAL INSPECTION FOUND THE BALLOON WAS TORN CIRCUMFERENTIALLY. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF BALLOON PINHOLE WAS UNABLE TO BE CONFIRMED DURING THE PRODUCT INVESTIGATION. BASED ON THE CONDITION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE BALLOON WAS TORN CIRCUMFERENTIALLY. THE PROBLEM COULD HAVE BEEN GENERATED DUE TO PROCEDURAL FACTORS AND INTERACTIONS ENCOUNTERED DURING THE PROCEDURE AND EXCESS PRESSURE. ALSO, IT IS POSSIBLE THAT INTERACTION WITH A SHARP SURFACE DURING/PREVIOUS PROCEDURE, COULD HAVE CAUSED THE PROBLEM FOUND ON THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO GI WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGEAL TRACT DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, BALLOON DILATATION WAS PERFORMED AND A PINHOLE IN THE BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A SECOND 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 USED IN THE ESOPHAGEAL TRACT DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, BALLOON DILATATION WAS PERFORMED AND A PINHOLE IN THE BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A SECOND 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 USED IN THE ESOPHAGEAL TRACT DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, BALLOON DILATATION WAS PERFORMED AND A PINHOLE IN THE BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A SECOND 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 |
|---|---|---|---|---|---|---|---|
| 188087 | CRE PRO GI | DILATOR, ESOPHAGEAL | KNQ | BOSTON SCIENTIFIC CORPORATION | M00558770 | 0035522440 | 08714729933885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |