CRE WIREGUIDED
Report
- Report Number
- 3005099803-2025-00419
- Event Type
- Malfunction
- Date Received
- February 11, 2025
- Date of Event
- January 20, 2025
- Report Date
- April 9, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FDF
- PMA / PMN Number
- K110833
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B: THE REMAINING PRO CODES (PRODUCT CODES) ARE FDT AND KNQ; REPORTED HERE AS PRO CODES (PRODUCT CODES) EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF A BALLOON BURST. BLOCK H11: INVESTIGATION RESULTS THE RETURNED CRE WIREGUIDED DILATATION BALLOON WAS ANALYZED, AND A VISUAL AND MICROSCOPIC EVALUATION FOUND THE BALLOON HAD A LONGITUDINAL TEAR. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES THAT THE REPORTED EVENT OF BALLOON BURST COULD NOT BE CONFIRMED. THE RETURNED DEVICE HAD A LONGITUDINAL TEAR AND COULD HAVE BEEN INTERPRETED BY THE CUSTOMER AS THE REPORTED EVENT OF BALLOON BURST. IT IS LIKELY THE LONGITUDINAL TEAR OCCURRED DUE TO FACTORS ENCOUNTERED DURING THE PROCEDURE, SUCH AS EXCESS PRESSURE, INTERACTION WITH OTHER DEVICES, OR ANATOMICAL FACTORS. ALSO, IT IS POSSIBLE THAT INTERACTION WITH ANY KIND OF SHARP SURFACE DURING OR PREVIOUS TO THE PROCEDURE COULD CREATE FRICTION ON THE BALLOON, CAUSING THE LONGITUDINAL TEAR DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.
BLOCK D2B: THE REMAINING PRO CODES (PRODUCT CODES) ARE FDT AND KNQ; REPORTED HERE AS PRO CODES (PRODUCT CODES) EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF A BALLOON BURST.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS INFLATED FIRST TO 16.5 MM AT 4.5 ATM THEN DEFLATED AND WENT UP TO 18 MM AT 7 ATM. THE BALLOON POPPED AT 6.5 ATM. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS INFLATED FIRST TO 16.5 MM AT 4.5 ATM THEN DEFLATED AND WENT UP TO 18 MM AT 7 ATM. THE BALLOON POPPED AT 6.5 ATM. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 |
|---|---|---|---|---|---|---|---|
| 1625266 | CRE WIREGUIDED | COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FDF | BOSTON SCIENTIFIC CORPORATION | M00558490 | 0032269665 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |