CRE PRO
Report
- Report Number
- 3005099803-2026-00687
- Event Type
- Malfunction
- Date Received
- February 23, 2026
- Date of Event
- January 13, 2026
- Report Date
- April 23, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729797562
- PMA / PMN Number
- K112994
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF A BALLOON BURST. IMDRF DEVICE CODE A040101 CAPTURES THE REPORTABLE EVENT OF A BALLOON FAILURE TO DEFLATE.
BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF A BALLOON BURST. IMDRF DEVICE CODE A040101 CAPTURES THE REPORTABLE EVENT OF A BALLOON FAILURE TO DEFLATE. BLOCK H11: THE RETURNED CRE PRO WIREGUIDED DILATATION BALLOON WAS ANALYZED, AND VISUAL INSPECTION FOUND A MECHANICAL CUT ALONG THE CATHETER, AFFECTING A PORTION OF THE CATHETER AND THE ENTIRE BALLOON SECTION. A SEGMENT OF THE MATERIAL WAS FOUND TO BE DETACHED AND WAS NOT RETURNED WITH THE DEVICE. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF BALLOON BURST AND BALLOON FAILURE TO DEFLATE WAS NOT CONFIRMED. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE DEVICE EXHIBITED A MECHANICAL CUT ALONG THE CATHETER AFFECTING THE BALLOON SEGMENT AND WITH A PORTION OF THE MATERIAL NOT RETURNED. THEREFORE, FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE CATHETER DETACHMENT CORRESPONDS TO AN INTENTIONAL ACTION PERFORMED BY THE PHYSICIAN DURING THE PROCEDURE, SPECIFICALLY CUTTING THE CATHETER AS A MEASURE TO FACILITATE DEVICE REMOVAL IN RESPONSE TO THE ENCOUNTERED DIFFICULTY. BASED ON ALL GATHERED INFORMATION AND THE ANALYSIS PERFORMED, THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS CAUSE NOT ESTABLISHED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCE'S, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION TO TREAT ESOPHAGEAL STENOSIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DILATION BALLOON RUPTURED DURING ESOPHAGEAL DILATION. THEY WERE NOT ABLE TO EASILY DEFLATE AND PULL OUT THE BALLOON, SO THEY HAD TO CUT THE CATHETER OF THE BALLOON FOR IT TO BE LOOSE ENOUGH FOR REMOVAL. NO PIECE OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS EXPECTED TO FULLY BE RECOVERED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION TO TREAT ESOPHAGEAL STENOSIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DILATION BALLOON RUPTURED DURING ESOPHAGEAL DILATION. THEY WERE NOT ABLE TO EASILY DEFLATE AND PULL OUT THE BALLOON, SO THEY HAD TO CUT THE CATHETER OF THE BALLOON FOR IT TO BE LOOSE ENOUGH FOR REMOVAL. NO PIECE OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS EXPECTED TO FULLY BE RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474070 | CRE PRO | CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC CORPORATION | M00558680 | 0036049395 | 08714729797562 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |