CRE WIREGUIDED
Report
- Report Number
- 3005099803-2025-00347
- Event Type
- Malfunction
- Date Received
- February 11, 2025
- Date of Event
- January 15, 2025
- Report Date
- April 29, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FDF
- UDI-DI
- 08714729339335
- PMA / PMN Number
- K110833
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 E1: INITIAL REPORTER'S FACILITY NAME IS (B)(6); REPORTED HERE AS THE FACILITY NAME EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H11: INVESTIGATION RESULTS - THE RETURNED CRE WIREGUIDED DILATATION BALLOON WAS ANALYZED, AND A VISUAL/MICROSCOPIC EVALUATION FOUND NO DAMAGE TO THE DEVICE. FUNCTIONAL INSPECTION WAS PERFORMED, THE BALLOON WAS INFLATED, AND IT WAS ABLE TO HOLD PRESSURE WITHOUT ANY ISSUE. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. THE RETURNED DEVICE WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS NO PROBLEM DETECTED.
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 E1: INITIAL REPORTER'S FACILITY NAME IS (B)(6); REPORTED HERE AS THE FACILITY NAME 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/MICROSCOPIC EVALUATION FOUND NO DAMAGE TO THE DEVICE. FUNCTIONAL INSPECTION WAS PERFORMED, THE BALLOON WAS INFLATED, AND IT WAS ABLE TO HOLD PRESSURE WITHOUT ANY ISSUE. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF BALLOON BURST WAS NOT CONFIRMED. THE RETURNED DEVICE WAS INFLATED AND WAS ABLE TO HOLD PRESSURE WITHOUT ANY ISSUE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS NO PROBLEM DETECTED.
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 E1: INITIAL REPORTER'S FACILITY NAME IS THE FIRST AFFILIATED HOSPITAL (B)(6); REPORTED HERE AS THE FACILITY NAME 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 BILIARY TRACT DURING A BILIARY DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PAPILLA DILATION, THE BALLOON BURST AT 9 ATM AND IT COULD NOT BE DILATED. 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON APRIL 2, 2025. THE PHYSICIAN REPORTED THAT THE BALLOON COULD NOT BE INFLATED DURING THE PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILIARY TRACT DURING A BILIARY DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PAPILLA DILATION, THE BALLOON BURST AT 9 ATM AND IT COULD NOT BE DILATED. 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILIARY TRACT DURING A BILIARY DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PAPILLA DILATION, THE BALLOON BURST AT 9 ATM AND IT COULD NOT BE DILATED. 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1514532 | CRE WIREGUIDED | COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FDF | BOSTON SCIENTIFIC CORPORATION | M00558400 | 0033978674 | 08714729339335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female |