CRE PULMONARY
Report
- Report Number
- 3005099803-2025-00669
- Event Type
- Malfunction
- Date Received
- March 5, 2025
- Date of Event
- February 6, 2025
- Report Date
- June 6, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KTI
- UDI-DI
- 08714729456209
- PMA / PMN Number
- K023337
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK G4: THE REMAINING PREMARKET/510(K) NUMBER IS K170759; REPORTED HERE AS PREMARKET/510(K) NUMBER EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK E1: INITIAL REPORTER'S FACILITY NAME IS THE SECOND AFFILIATED HOSPITAL OF CHONGQING MEDICAL UNIVERSITY; REPORTED HERE AS THE FACILITY NAME EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF A BALLOON DAMAGE.
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 G4: THE REMAINING PREMARKET/510(K) NUMBER IS K170759; REPORTED HERE AS PREMARKET/510(K) NUMBER EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF A BALLOON DAMAGE. BLOCK H11: INVESTIGATION RESULTS THE RETURNED CRE PULMONARY DILATATION BALLOON WAS ANALYZED, AND A VISUAL AND MICROSCOPIC EVALUATION FOUND NO DAMAGES. FUNCTIONAL TESTING WAS PERFORMED, AND THE BALLOON WAS INFLATED WITHOUT A PROBLEM AND WAS ABLE TO HOLD PRESSURE. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES THAT THE REPORTED EVENT OF BALLOON DAMAGED/DEFECTIVE COULD NOT BE CONFIRMED. THE RETURNED DEVICE HAD NO VISUAL DAMAGES, WAS INFLATED WITHOUT A PROBLEM, AND WAS ABLE TO HOLD PRESSURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS NO PROBLEM DETECTED.
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 G4: THE REMAINING PREMARKET/510(K) NUMBER IS K170759; REPORTED HERE AS PREMARKET/510(K) NUMBER EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H2 (ADDITIONAL INFORMATION): BLOCK E1 (INITIAL REPORTER ADDRESS AND ZIP/POST CODE) HAVE BEEN UPDATED. BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF A BALLOON DAMAGE. BLOCK H11: INVESTIGATION RESULTS- THE RETURNED CRE PULMONARY DILATATION BALLOON WAS ANALYZED, AND A VISUAL AND MICROSCOPIC EVALUATION FOUND NO DAMAGES. FUNCTIONAL TESTING WAS PERFORMED, AND THE BALLOON WAS INFLATED WITHOUT A PROBLEM AND WAS ABLE TO HOLD PRESSURE. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES THAT THE REPORTED EVENT OF BALLOON DAMAGED/DEFECTIVE COULD NOT BE CONFIRMED. THE RETURNED DEVICE HAD NO VISUAL DAMAGES, WAS INFLATED WITHOUT A PROBLEM, AND WAS ABLE TO HOLD PRESSURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS NO PROBLEM DETECTED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS BEING PREPARED TO BE USED IN THE TRACHEA DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, WHEN THE PACKAGE WAS OPENED, THE FRONT END OF THE CATHETER WAS FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS BEING PREPARED TO BE USED IN THE TRACHEA DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, WHEN THE PACKAGE WAS OPENED, THE FRONT END OF THE CATHETER WAS FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS BEING PREPARED TO BE USED IN THE TRACHEA DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, WHEN THE PACKAGE WAS OPENED, THE FRONT END OF THE CATHETER WAS FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449180 | CRE PULMONARY | BRONCHOSCOPE ACCESSORY | KTI | BOSTON SCIENTIFIC CORPORATION | M00550320 | 0031223271 | 08714729456209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female |